The effect of manual therapy and exercise in patients with chronic low back pain: Double blind randomized controlled trial

Abstract

BACKGROUND AND OBJECTIVES:

To determine the effects of spinal stabilization exercises (SSE) and manual therapy methods on pain, function and quality of life (QoL) levels in individuals with chronic low back pain (CLBP).

METHODS:

A total of one-hundred thirteen patients diagnosed as CLBP were enrolled to the study. The patients allocated into Spinal Stabilization group (SG) and manual therapy group (MG), randomly. While SSE performed in SG, soft tissue mobilizations, muscle-energy techniques, joint mobilizations and manipulations were performed in MG. While the severity of pain was assessed with Visual Analog Scale (VAS), Oswestry Disability Index (ODI) and Short Form 36 (SF-36) assessments were performed to evaluate the functional status and QoL, respectively. All assessments were repeated before and after the treatment. Results: Intragroup analyses both treatments were effective in terms of sub parameters of pain, function and life quality ( $p<$ 0.05). Inter group analyses, there was more reduction in pain and improvement in functional status in favor of MG ( $p<$ 0.05).

CONCLUSIONS:

This study showed that SSE and manual therapy methods have the same effects on QoL, while the manual treatment is more effective on the pain and functional parameters in particular.

Keywords

Low back pain pain rehabilitation exercise quality of life

1. Background

Many people have experienced low back pain at any point in their lives [1] and ongoing low back pain at least three months defined chronic low back pain (CLBP). CLBP effects daily living activities of a person ranging from standing up, walking, bending over, lifting, traveling, social interaction, dressing to sleeping [2]. While the increased number of people with CLBP causes economic burden for countries both workforce loss and expensive treatment costs, living with ongoing pain causes depression, anxiety, deterioration in QoL for patients themselves.

The problems seen in patients with CLBP originated back pain related physical disability. There is growing evidence that improvement in QOL and anxiety is associated with gaining functional restoration and treating CLBP become important. Surgery, minimally invasive technics and physiotherapy and rehabilitation approaches have been applied in the treatment of CLBP. The most frequently applied physiotherapy methods reported in the literature are TENS, thermal agents, mobilizations and exercises. Such approaches, also known as conventional approaches, have been treating patients with CLBP, alleviating the severity and frequency of the pain, eliminating the functional limitations, contributing positively to the improvement in QoL and avoiding workforce losses [1, 2, 3, 4, 5, 6, 7].

Figure 1.

Flow diagram.

Manipulation and manual treatments are the most applied methods within physiotherapy approaches in recent years [8]. Through manipulations, manual treatment practices and biomechanical loading, the physiology of the muscle is altered by stimulating the neurons within the muscle tissue and the pain is reduced in a short period by increasing in the joint mobility based on the gate control theory [1, 2, 3]. The manipulations have been reported to be an efficient treatment method in patients suffering from acute and CLBP [1]. However the clinical use of manual therapy practices is getting popular, evidence based and studies comparing manual methods and exercise therapy still lack [1, 3, 4, 5]. For this reason, we have conducted the present study with a view to identifying the effects of the spinal stabilization exercises and manual therapy practices on pain, function and QoL levels of the patients suffering from LBP in a comparative manner.

2. Objectives

This study was conducted with the aim of determining whether manual therapy or spinal stabilization exercise was effective in pain, functional status and QoL.

3. Sample size

Randomization was performed by drawing lots among

the patients who had applied for the treatment and met the participation criteria.

We required 112 patients in a balanced design, or 32 patients in each group assuming an $\alpha$ level of 0.05, two tailed test, and a power of 0.80.

Table 1
Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Diagnosed with CLBP	Undergone spine surgery or failed back surgery
Pain severity of $>$ 3 as per VAS	Having scoliosis
Ongoing pain for at least 3 months	Having spinal neoplasm or metastatic disease
	Having progressive neuropathy or progressive lumbosacral radiculopathy
	Having rheumatoid arthritis with advanced joint involvement
	Ongoing pharmaceutical medication
	Having neurologic disease in addition to CLBP
	Having systematic diseases and bladder disinfection

4. Method

The study has been conducted on patients diagnosed with CLBP and who were referred to the Low Back and Neck Health Unit of the Hacettepe University, Health Sciences Faculty, Physiotherapy and Rehabilitation Department. Necessary authorization and permits for this study have been secured from the Non-Entrepreneurial Clinical Studies Ethical Board of Hacettepe University, board resolution number GO131550-11. Clinical trial number is NCT02696057. Out of 245 patients who had applied for a physiotherapy program from various polyclinics, 197 patients were eligible for this study. Fifty-three refused to participate in the study, 29 failed to make time for the study schedule and 2 were excluded from the study as they failed to show up for the final assessments. Flow diagram is seen in Fig. 1.

This study conducted with 113 patients with CLBP who were allocated randomized into two groups: spinal stabilization exercise group (SG) and manual therapy group (MG). Patients were considered eligible if they met the following inclusion and exclusion criteria given in Table 1.

4.1 Randomization and blinding

Eligible patients allocated in two groups by using block randomization method. According to computer generated random order, the patients were led to different physiotherapist. All the assessments were done before and after therapy with same therapist who was not assigned in treatment sessions. In MG, treatment was performed under the supervision of the same physiotherapist who practiced manual technics for ten years. In SG, exercise was performed another therapist. Statistician did not know any personal data about subjects. Outcome assessor, statistician and physiotherapist who involved in treatment sessions were blinded.

4.2 Interventions

Individualized spinal stabilization exercises were performed under the supervision of same physiotherapist in SG. The program started with elementary/basic level exercises which included diaphragm respiration and the co-contraction of Transversus Abdominus (TA) and core muscles, and moved on to intermediate and advanced level exercises (additional extremity movements with the contraction of TA and Multifidus muscles, trunk stabilization and maintaining balance over a ball, maintaining balance while standing, etc.) [6, 7]. Advancing in SG according to weeks was shown in below. In all weeks, it is important to keep contracting TA and Multifidus muscles. The criteria moved on to next week is to keep contracting the TA and Multifidus muscles through ten seconds and be able to repeat it ten times for all exercise of current step [8].

First week: Contracting TA and Multifidus muscles together with diaphragm respiration appropriately in supine position keeping good postural alignment.

Second week: Different positions which included prone, sitting, standing and crawling positions added.

Third week: Side-lying positions and some stretching exercise were added. For example: stretching for hip flexor, back extensor or hamstring muscles.

Fourth week: Bilateral movements and closed chain exercises were added.

Fifth week: Alternative movements and resistive band exercise were added. For example: resistive (band is chosen according to patient’s strength) wrist extension in crawling position, resistive knee extension in crawling position, resistive shoulder flexion in standing or sitting position.

Sixth week: Exercise ball added to complicate the movements. For example: sitting on ball, Mini Squat with keeping the ball between back and wall.

In the MG a series of methods consisting of soft tissue mobilizations, muscle-energy techniques, joint mobilization and/or manipulations applied to patients depending on patient’s medical issue. Soft tissue mobilizations were included myofascial stretching for superficial and deep muscles, transverse friction for inter-spinous and supraspinous ligaments. Muscle-energy techniques were included post-isometric relaxations for quadratus lumborum and piriformis muscles. For post-isometric relaxation, target muscle was located in stretching positon and asked for the patients contracting the muscle softly almost 8 seconds up to 30% of maximum voluntary contraction. It is repeated according to relaxation of muscle. Joint mobilization and manipulation was done according to sacroiliac mobility test. Sacroiliac mobility was assessed with standing flexion forward test, Gillet test, Piedallu Sign [9, 10]. According to test results anterior or posterior mobilization or manipulation were applied.

Both groups received totally 18 sessions of therapy which lasted six weeks with three times in a week. One therapy session was lasting almost sixty minutes.

4.3 Outcomes

Demographic characteristics of patients including age, sex, height, weight, and history of physiotherapy interventions were recorded before any therapy. Sensorial loss assessed with Semmes-Weinstein monofilaments according to lower extremity dermatomes. It is known that Semmes-Weinstein monofilaments used for gnostic sensory measurements [11, 12]. The monofilament testing applied from 2.83 and higher. The monofilaments applied to the skin three times and if the patient felt stimulus, the point was recorded. For detecting sacroiliac joint dysfunction five sacroiliac joint provocation tests which consists of FABER, Gaenslen, Shear, sacroiliac compression and Sacroiliac distraction tests. At least three or more positive response of these tests indicated sacroiliac joint dysfunction [13, 14].

Every patient was evaluated according to the following clinical assessments both before and after the therapy by same physiotherapist different from the therapist who applied interventions.

Visual Analog Scale (VAS): The pain severity was rated by patients in every sessions of before treatment with VAS where 10-cm-long line’s left side indicates ‘no pain’ and right side indicates ‘unbearable pain’. The distance between the point marked by the patient and the 0 point is measured in centimeters and the value reveals the severity of the pain felt by the patient [15].

Oswestry Disability Index (ODI): Turkish version of ODI was used to measure perceived functional disability levels due to chronic low back pain. This self-administered, reliable and valid questionnaire consists of 10 items, each having a score of 0 to 5. ODI total scores ranges from 0 (no disability) to 50 (severe disability) [6, 16].

Short form 36 (SF-36): Turkish version of SF-36 was used to measure the changes in QoL levels due to chronic low back pain. This scale consists 36 items and assesses various sub-parameters such as physical function, physical role difficulty, pain, general health, energy, social function, emotional role difficulty, mental health, etc. Each sub-parameter is scored on a scale of 0 to 100, where 0 is the lowest and 100 is the highest score [17, 18].

Minimal detectable change/Minimal clinical improvement were set at $>$ 20 mm for VAS and 12.8 point for ODI from baseline to the end of treatment [19, 20].

Table 2
Demographic data of subjects

	Manual therapy	Spinal stabilization	$p$
	Group ( $n=$ 57)	Group ( $n=$ 56)
Age (year)	41.6 $\pm$ 12.9	43.1 $\pm$ 14.3	0.45
Sex (F/M)	35/22	32/24	0.37
BMI (kg/m ${}^{2}$ )	26.2 $\pm$ 3.5	26.1 $\pm$ 4.4	0.89
Sacroiliac	(%)26.3	(%)25	0.75
dysfunction
Sensorial loss	(%)24.6	(%)19.6	0.87

BMI: Body Mass Index.

Table 3

Changes in outcome measures

	Groups	Before treatment	The end of the treatment	$P$ value
VAS (resting)	Manual therapy Spinal stabilization $P$ value	6.9 $\pm$ 1.48 [6.9–1.48] 5.27 $\pm$ 2.55 [2.2–4.6] $<$ 0.003*	2.08 $\pm$ 1.2 [1.4–3] 2.1 $\pm$ 1.6 [0.8–2.2] 0.979	$<$ 0.001 $<$ 0.001 $<$ 0.001**
VAS (activity)	Manual therapy Spinal stabilization $P$ value	8.26 $\pm$ 1.3 [7.5–8.9] 6.69 $\pm$ 1.6 [5.9–7.4] 0.001**	3.63 $\pm$ 1.8 [2.6–4.6] 3 $\pm$ 2.43 [1.9–4]0.083	$<$ 0.001 $<$ 0.001 0.229
ODI	Manual therapy Spinal stabilization $P$ value	46.4 $\pm$ 18.1 43.5 $\pm$ 17.1 0.37	18.9 $\pm$ 13.4 23.5 $\pm$ 14.2 0.8	$<$ 0.001 $<$ 0.001 0.003*
SF-PF	Manual therapy Spinal stabilization $P$ value	40.8 $\pm$ 20.9 36.9 $\pm$ 15.6 0.30	69.2 $\pm$ 18.7 59.4 $\pm$ 15.2 0.004*	$<$ 0.001 $<$ 0.001 0.17
SF-RP	Manual therapy Spinal stabilization $P$ value	24.05 $\pm$ 30 29.5 $\pm$ 22.1 0.019*	58.9 $\pm$ 33.7 54.4 $\pm$ 23.02 0.22	$<$ 0.001 $<$ 0.001 0.11
SF-BP	Manual therapy Spinal stabilization $P$ value	34.9 $\pm$ 17.6 37.1 $\pm$ 10.2 0.31	59.3 $\pm$ 18.4 54.2 $\pm$ 13.2 0.096	$<$ 0.001 $<$ 0.001 0.009*
SF-GH	Manual therapy Spinal stabilization P value	49.1 $\pm$ 12.1 47.1 $\pm$ 12.4 0.17	60.2 $\pm$ 13.7 56.7 $\pm$ 10.6 0.279	$<$ 0.001 $<$ 0.001 0.675
SF-VT	Manual therapy Spinal stabilization $P$ value	43.6 $\pm$ 14.6 43.6 $\pm$ 9.9 0.85	53.1 $\pm$ 16.8 50.8 $\pm$ 10.9 0.375	$<$ 0.001 $<$ 0.001 0.591
SF-SF	Manual therapy Spinal stabilization $P$ value	45.2 $\pm$ 24.2 39.2 $\pm$ 14.3 0.110	61.9 $\pm$ 20.3 56.6 $\pm$ 18 0.190	$<$ 0.001 $<$ 0.001 0.964
SF-RE	Manual therapy Spinal stabilization $P$ value	42.9 $\pm$ 38.7 45.6 $\pm$ 26.7 0.591	65 $\pm$ 31.5 67.2 $\pm$ 24 0.766	$<$ 0.001 $<$ 0.001 0.611
SF-MH	Manual therapy Spinal stabilization $P$ value	52.6 $\pm$ 17.3 44.2 $\pm$ 14 0.015*	61.8 $\pm$ 17.8 57.1 $\pm$ 14.1 0.327	$<$ 0.001 $<$ 0.001 0.086

* $p<$ 0.05, ** $p<$ 0.001. VAS: Visual Analog Scale, ODI: Oswestry Disability Index, SF: Short Form 36, PF: Physical Functioning, RP: Role Physical, BP: Bodily Pain, GH: General Health, VT: Vitality, SF: Social Functioning, RE: Role Emotional, MH: Mental Health.

Table 4

Minimal detactable change frequencies as to groups

	Manual therapy		Spinal stabilization
	( $n=$ 57)		( $n=$ 56)
	$n$ (%)	ES	$n$ (%)	ES
VAS (resting)	55 (96)	3.5	50 (89)	1.4
VAS (activity)	57 (100)	2.87	54 (96)	1.72
ODI	49 (85)	1.6	35 (62)	1.26

ES: Effect size.

4.4 Statistical analysis

The SPSS statistical 16.0 software (Statistical Package for Social Sciences Inc. Chicago, IL, USA) was used for the statistical analysis. The compatibility of the data with normal distribution was reviewed visually (by histogram and probability charts) and through analytical methods. The Mann-Whitney U test was conducted to identify the difference between the groups, while the Wilcoxon test was conducted to determine the changes occurring after the treatment. The statistical significance level was acknowledged as $p<$ 0.05.

5. Results

There were 67 female and 46 male patients with a mean age of 42.4 $\pm$ 13.6 years between the range of 20 and 73 years. The baseline mean scores of ODI and VAS were 45 $\pm$ 17.6 and 6.4 $\pm$ 1.5, respectively. All participants had similar data in terms of age, body mass index, profession, family history, sensorial deficits, sacroiliac joint dysfunction ( $p>$ 0.05). Demographic characteristics of subjects according to groups were seen in Table 2.

For both groups there was significant reduction in mean pain severity after treatment as to baseline ( $p<$ 0.001) with no significant difference in pain severity during activity between groups ( $p>$ 0.05). There were significant reductions in functional disability scores according to ODI both intra group and inter group analyses. Improving in disability scores was higher in the favor of MG ( $p<$ 0.05). There were significant improvements in QoL levels according to SF-36 after treatment as to baseline ( $p<$ 0.001), with no significant difference among groups except the “bodily pain” subgroup of SF-36 ( $p>$ 0.05). Changes in outcome measures including pain severity, ODI and SF-36 were shown in Table 3.

The frequencies of data which had minimal detectable change were shown in Table 4. MG showed higher effect size in terms of observed changes in pain severity and functional improvement.

6. Conclusion

We investigated the effectiveness of spinal stabilization exercise and manual therapy application on pain functional disability and quality of live in patients with CLBP. Although both treatments showed effective reduction in pain, improvement in function and QoL, manual therapy was found more effective in terms of functional improvement and pain relief.

The studies conducted up until 2008 on chronic non-specific LBP suggest that exercise and cognitive trainings as well as manipulation practices offer an intermediate level of evidence [21]. Recent systemic reviews suggested that the exercise should be used in physiotherapy programs due to their high evidence levels [22]. Additionally some studies showed strong evidence for effectiveness of exercise therapy in chronic stages and moderate evidence for ineffectiveness in acute stages [23]. Systematic reviews focused on exercise therapy highlighted that exercise programs must be individualized and needed regular therapist follow up [24]. Based on this idea, patient-specific posture, stretching and strengthening exercises included in both groups and spinal stabilization exercises applied with therapist guide. Stabilization exercises were proved to be short and long term positive effects by supporting dynamic control to lumbar spine and prevent re-injury [25].

Due to nature of CLBP, it is difficult to standardize the interventions, so the present study conducted with the same methods and different direction as to patient’s medical concern. Clinically, manual therapy combined with exercise for management of pain in patients with CLBP so postural, stretching and strengthening exercise was included to the present study.

When the studies reporting positive results about the effects of manual therapy and spinal stabilization exercises on the functionality of the patients with LBP are reviewed [22, 26, 27], it is not surprising to see functionality related improvements in both groups as a result of this study. The present study and our clinical observations also confirmed that the patients in both groups were able to move around more comfortably at the end of therapy. It is known that Sacroiliac joint provide additional motion and by the way it helps L5-S1 function [28]. It is confirmed that the re-functioning of the sacroiliac joint and spinal mobility – which were initially evaluated with special tests and found dysfunctional – through manual therapy and spinal stabilization exercises interventions had positive results on functional restoration.

Aure et al. applied 8 week manual and general exercise therapy and found manual therapy was more effective than exercise therapy in terms of pain and functional status [29]. Although treatment period was different from present study, we reached similar results with 6 week manual therapy and exercise intervention. In contrast to Geisser et al. [30], the result of present study support the notion that manual therapy have significant improvement in functional disability and pain severity. Rasmussen et al. [31] found that stabilization exercise was more effective in terms of functional disability than manual therapy in 12 month follow up due to exercise therapy was active approach in comparison to the manual therapy. The subjects in manual therapy group of our study performed postural, stretching and strengthening exercise in addition to patient specific manual therapy approaches and it is possible that exercise combined with manual therapy has a greater effect on functional disability and pain relief than stabilization exercise group.

Although the pain severity in manual therapy group was higher than spinal stabilization group at baseline, improvement after treatment was surprisingly higher in manual therapy group. This result was also support the manual therapy was more effective than spinal stabilization in terms of pain relief. According to minimal detectable change of assessed variables more improved subjects were detected in manual therapy group in the present study. There were different cut off points for minimal detectable change for ODI and VAS, the maximum values shown in recent papers were used to prevent type 2 error in the present study. Pain adversely affects the QoL individuals with LBP. Kosinski et al. [32] reported that the values in all categories of SF-36 were found to be low in patients with CLBP; the most highlighted ones were physical function, physical role limitation, pain, social function and physical variable scores which were particularly lower than age and gender matched healthy individuals. Similarly, another study conducted with 350 LBP patients found that 8 sub-scores of SF-36 were poorer than the general healthy population. The lowest results were identified in the subscales of physical function, physical role limitation and pain [33].

Some limitations were noted for this study. Assessed outcome measures were planned to determine only effectiveness or superiority of treatments and it is not enough to make a cost efficiency calculation. Due to outcome measures performed only one assessor, it was difficult to fit the schedule to the patient. If the present study set interval assessments which treatment was more effective in lesser time frame, we had more discussion and richer results in terms of the controversial manual therapy and different physiotherapy practices.

In conclusion, this study suggest that recommendations and exercises intended for low back health as well as the spinal stabilization exercises and manual treatment methods commonly practiced have the same effect on pain, function and life quality. On the other hand, manual treatment is found to be more effective particularly in terms of pain and functionality parameters. This study relies on the most frequently used methods in the literature that offer high evidence values. We believe that exercise practices are important in planning treatments for the patients with chronic LBP and that the treatment practices aiming to improve pain relief, clinical and functional conditions of the patients will also improve the functionality and life quality. Moreover, monitoring the functionality and life quality of the patients will also be beneficial in following up on their response to the treatment. For further studies the long-term follow up and cost effectiveness calculation is needed to make precise comments.

Conflict of interest

None to report.

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The effect of manual therapy and exercise in patients with chronic low back pain: Double blind randomized controlled trial

Abstract

BACKGROUND AND OBJECTIVES:

METHODS:

CONCLUSIONS:

Keywords

1. Background

3. Sample size

Table 1 Inclusion and exclusion criteria

4.1 Randomization and blinding

4.2 Interventions

4.3 Outcomes

Table 2 Demographic data of subjects

5. Results

6. Conclusion

Conflict of interest

References

Table 1
Inclusion and exclusion criteria

Table 2
Demographic data of subjects