Primary studies included in this broad synthesis

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Publication Thread

Malmivaara and Slätis (provisional publication thread name)

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Publication Thread

SPORT (Spine Patient Outcomes Research Trial)

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Primary study

Unclassified

Efficacy of exercise and ultrasound in patients with lumbar spinal stenosis: a prospective randomized controlled trial.

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Journal Clinical rehabilitation
Year 2010
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This article is included in 3 Systematic reviews Systematic reviews (3 references) 1 Broad synthesis Broad syntheses (1 reference)

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OBJECTIVE: To assess the effectiveness of therapeutic exercises alone and in combination with a single physical agent - ultrasound - in patients with lumbar spinal stenosis. DESIGN: Randomized, prospective, controlled trial. SETTING: Department of Physical Medicine and Rehabilitation, University Hospital. SUBJECTS: Forty-five patients presenting with symptoms of neurological claudication and magnetic resonance image-proven lumbar spinal stenosis were assigned to one of three groups: ultrasound plus exercise group (group 1, n =15), sham ultrasound plus exercise group (group 2, n= 15) and no exercise - no treatment group (control group, n = 15). INTERVENTIONS: Stretching and strengthening exercises for lumbar, abdominal, leg muscles as well as low-intensity cycling exercises were given as therapeutic exercises. Ultrasound was applied with 1 mHz, 1.5 W/cm(2) intensity, in continuous mode on the back muscle for 10 minutes in group 1 while ultrasound on/off mode was applied in group 2. MAIN OUTCOME MEASURES: Before and after a three-week period, all subjects were evaluated by pain, disability, functional capacity and consumption of analgesic. RESULTS: Thirty-two of the participants were women and 13 were men, with an average age of 53.2 +/- 12.68 years (range 25-82 years). After a three-week treatment period, leg pain decreased in group 1 (-1.47 +/- 3.02) and group 2 (-2.47 +/- 3.75) compared with the control group (P<0.05). Disability score decreased in group 1 (-3.94 +/- 7.20) and group 2 (-7.80 +/- 10.26) compared with control group (P<0.05). We did not find any statistically significant difference between groups 1 and 2 (P>0.05). The amount of analgesic consumption is significantly less in the group with ultrasound application compared to that in the control group (P<0.05). CONCLUSION: The results of our study suggest that therapeutic exercises are effective for pain and disability in patients with lumbar spinal stenosis and that addition of ultrasound to exercise therapy lowers the analgesic intake substantially.

Primary study

Unclassified

Effectiveness of physical therapy and epidural steroid injections in lumbar spinal stenosis

Journal Spine
Year 2009
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This article is included in 8 Systematic reviews Systematic reviews (8 references) 1 Broad synthesis Broad syntheses (1 reference)

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STUDY DESIGN.: Randomized single-blind controlled trial. OBJECTIVE.: We aimed to compare the effects of epidural steroid injections and physical therapy program on pain and function in patients with lumbar spinal stenosis (LSS). SUMMARY OF BACKGROUND DATA.: LSS is one of the most common degenerative spinal disorders among elderly population. Initial treatment of this disabling painful condition is usually conservative including analgesics, nonsteroidal anti-inflammatory drugs, exercise, physical therapy, or epidural steroid injections. Owing to lack of sufficient data concerning the effectiveness of conservative treatment in LSS, we aimed to compare the effectiveness of epidural steroid injections and physical therapy program in a randomized controlled manner. METHODS.: A total of 29 patients diagnosed as LSS were randomized into 3 groups. Group 1 (n = 10) received an inpatient physical therapy program for 2 weeks, group 2 (n = 10) received epidural steroid injections, and group 3 (n = 9) served as the controls. All study patients additionally received diclofenac and a home-based exercise program. The patients were evaluated at baseline, 2 weeks, 1 month, 3 months, and 6 months after treatment by finger floor distance, treadmill walk test, sit-to-stand test, weight carrying test, Roland Morris Disability Index, and Nottingham Health Profile. RESULTS.: Both epidural steroid and physical therapy groups have demonstrated significant improvement in pain and functional parameters and no significant difference was noted between the 2 treatment groups. Significant improvements were also noted in the control group. Pain and functional assessment scores (RMDI, NHP physical activity subscore) were significantly more improved in group 2 compared with controls at the second week. CONCLUSION.: Epidural steroid injections and physical therapy both seem to be effective in LSS patients up to 6 months of follow-up. © 2009, Lippincott Williams & Wilkins.

Publication Thread

SPORT (Spine Patient Outcomes Research Trial)

This thread includes 2 references

Primary study

Unclassified

The efficacy of physical therapy and physical therapy plus calcitonin in the treatment of lumbar spinal stenosis

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Journal Yonsei medical journal
Year 2009
Links Pubmed DOI PubMed Central

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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Purpose: The aim of our study was to compare the efficacy of physical therapy alone and in combination with calcitonin in patients with neurogenic claudication (NC). Materials and Methods: In this single blind, and randomized study, patients with lumbar spinal canal stenosis who were diagnosed by clinical findings and MRI and having NC were included. Patients were observed for 8 weeks and evaluated before and after treatment. Patients were randomized between the salmon calcitonin 200 U/day + physical therapy (n = 23) (Group 1) and paracetamol 1,500 mg/day + physical therapy (n = 22) (Group 2) treatment groups. Both groups received the same physical therapy (interferential current + hot pack + short wave diathermy) and exercise protocol. The association of various clinical and functional parameters was assessed statistically by using paired and unpaired t test, chi square test and McNemar's test. p < 0.05 indicated statistical significant. Results: Mean age of the patients in Group 1 was 57.6 ± 11.2 and in Group 2 54.5 ± 10.6 years. Before treatment, there were no significant differences between groups with respect to age, body mass index, spinal axial diameter, Visual Analogue Scale (VAS), spinal mobility, functional status and walking distance (p > 0.05). After 8 weeks of treatment, both groups benefited significantly with respect to VAS, functional status and walking distance (p < 0.001). There was no statistically significant difference between groups (p > 0.05). Conclusion: In 45 patients with lumbar spinal stenosis who received 8 weeks of treatment, concomitant use of calcitonin with physical therapy and exercise did not have any benefical effect on the patient's pain, functional status, lumbar mobility and walking distance. © Copyright: Yonsei University College of Medicine 2009.

Primary study

Unclassified

The efficacy of prostaglandin E1 derivative in patients with lumbar spinal stenosis

Journal Spine
Year 2009
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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STUDY DESIGN. Randomized controlled trial. OBJECTIVE. To examine the effect of limaprost, an oral prostaglandin (PG) E1 derivative, on health-related quality of life (HRQOL) in patients with symptomatic lumbar spinal stenosis (LSS), compared to etodolac, a NSAID. SUMMARY OF BACKGROUND DATA. Limaprost, an oral PGE1 derivative, was developed in Japan to treat numerous ischemic symptoms of thromboangiitis obliterans (TAO) and LSS. Previous studies have demonstrated the effectiveness of limaprost in the symptoms in patients with LSS. However, the evidence for effect on patient-reported outcomes, such as patient's HRQOL or satisfaction, is limited. METHODS. This study was conducted at 4 study sites in Japan. Briefly, inclusion criteria were: age between 50 and 85 years; presence of both neurogenic intermittent claudication (NIC) and cauda equina symptoms (at least presence of bilateral numbness in the lower limbs); and MRI-confirmed central stenosis with acquired degenerative LSS. Limaprost (15 μg/d) or etodolac (400 mg/d) was administered for 8 weeks. The primary outcome was Short Form (SF)-36, and the secondary outcomes were the verbal rating scale of low back pain and leg numbness, walking distance, subjective improvement, and satisfaction. RESULTS. A total of 79 participants were randomized (limaprost:etodolac = 39:40). Thirteen participants withdrew from the study (limaprost:etodolac = 5:8) and 66 completed the study (limaprost:etodolac = 34:32). Comparisons showed that limaprost resulted in significantly greater improvements in the SF-36 subscales of physical functioning, role physical, bodily pain, vitality, and mental health. Limaprost was also significantly better than etodolac for leg numbness, NIC distance, and subjective improvement and satisfaction. In the subgroup analysis stratified by symptom severity, limaprost seemed more effective for milder symptoms. No serious adverse effects were reported in either treatment group. CONCLUSION. In this study, limaprost was found to be efficacious on most outcome measures, such as HRQOL, symptoms and subjective satisfaction, in LSS patents with cauda equina symptoms. © 2009 Lippincott Williams & Wilkins, Inc.

Primary study

Unclassified

The efficiency of gabapentin therapy in patients with lumbar spinal stenosis.

Journal Spine
Year 2007
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This article is included in 3 Systematic reviews Systematic reviews (3 references) 1 Broad synthesis Broad syntheses (1 reference)

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STUDY DESIGN: Randomized controlled study. OBJECTIVES: To investigate the efficacy of treatment with gabapentin on the clinical symptoms and findings in patients with lumbar spinal stenosis (LSS). SUMMARY OF BACKGROUND DATA: LSS is a syndrome resulting from the narrowing of the lumbar nerve root canal, spinal canal, and intervertebral foramen, causing compression of the spinal cord. The most significant clinical symptom in patients with LSS is neurologic intermittent claudication (NIC). Gabapentin, which has been used in the treatment of neuropathic pain, may be effective in the treatment of symptoms associated with LSS. METHODS: Fifty-five patients with LSS, who had NIC as the primary complaint, were randomized into 2 groups. All patients were treated with therapeutic exercises, lumbosacral corset with steel bracing, and nonsteroidal anti-inflammatory drugs. The treatment group received gabapentin orally in addition to the standard treatment. RESULTS: Gabapentin treatment resulted in an increase in the walking distance better than what was obtained with standard treatment (P = 0.001). Gabapentin-treated patients also showed improvements in pain scores (P = 0.006) and recovery of sensory deficit (P = 0.04), better than could be attained with the standard treatment. CONCLUSION: Based on the results of our pilot study, extensive clinical studies are warranted to investigate the role of gabapentin in the management of symptomatic LSS.

Primary study

Unclassified

Treadmill walking with body weight support is no more effective than cycling when added to an exercise program for lumbar spinal stenosis: a randomised controlled trial.

Authors Pua YH , Cai CC , Lim KC
Journal The Australian journal of physiotherapy
Year 2007
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QUESTION: Is 6 weeks of treadmill walking with body weight support more effective than cycling in people with lumbar spinal stenosis when added to an exercise program? DESIGN: Randomised controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. PARTICIPANTS: Sixty-eight patients aged 58 (SD 8) with symptoms of lumbar spinal stenosis for 12 weeks (SD 49). INTERVENTION: Participants performed either treadmill with body weight support or cycling, twice weekly, for 6 weeks. Both groups also received an exercise program consisting of heat, lumbar traction, and flexion exercises. OUTCOME MEASURES: The primary outcome was disability measured using the modified Oswestry Disability Index. Secondary outcomes were disability, measured using the Roland-Morris Disability Questionnaire, pain severity, and patient perceived benefit. Measures were collected midway through intervention at 3 weeks and after intervention at 6 weeks. RESULTS: There was no difference between the groups in reduction in disability or pain over the 6-week intervention period. The between-group difference in the modified Oswestry Disability Index was 3.2 points (95% CI -3.1 to 7.7) at 6 weeks, and in pain severity was 2 mm on a 100 visual analogue scale (95% CI -5 to 10). Furthermore, the wide confidence intervals associated with estimates of patient benefit are consistent with no difference between the two groups. However, both groups did improve. CONCLUSION: Treadmill with body weight support and cycling may be equally effective in the conservative management of people with lumbar spinal stenosis. However, the improvement observed in both groups was probably a combination of the intervention and the natural course of recovery of lumbar spinal stenosis.

Primary study

Unclassified

Randomised placebo-controlled trial on the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis.

Authors Tafazal SI , Ng L , Sell P
Journal European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
Year 2007
Links Pubmed DOI PubMed Central
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This is a double blind randomised controlled trial to assess the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis. The trial compared the outcome of salmon calcitonin nasal spray to placebo nasal spray in patients with MRI confirmed lumbar spinal stenosis. Lumbar spinal stenosis is one of the commonest conditions encountered by spine surgeons. It more frequently affects elderly patients and lumbar decompression has been used to treat the condition with variable success. Non operative measures have been investigated, but their success ranges from 15% to 43% in patients followed up for 1-5 years (Simotas in Clin Orthop 1(384):153-161, 2001). Salmon calcitonin injections have been investigated in previous trials and may have a treatment effect. Nasal salmon calcitonin has become available and if effective would have advantages over injections. Forty patients with symptoms of neurogenic claudication and MRI proven lumbar spinal stenosis were randomly assigned either nasal salmon calcitonin or placebo nasal spray to use for 4 weeks. This was followed by a 'washout' period of 6 weeks, and subsequent treatment with 6 weeks of nasal salmon calcitonin. Standard spine outcome measures including Oswestry disability index (ODI), low back outcome score, visual analogue score and shuttle walking test were administered at baseline, 4, 10 and 16 weeks. Twenty patients received nasal salmon calcitonin and twenty patients received placebo nasal spray. At 4 weeks post treatment there was no statistically significant difference in the outcome measures between the two groups. The change in ODI was a mean 1.3 points for the calcitonin group and 0.6 points for the placebo group (P = 0.51), the mean change in visual analogue score for leg pain was 10 mm in the calcitonin group and 0 mm in the placebo group (P = 0.51). There was no significant difference in walking distance between the two groups, with a mean improvement in walking distance of 21 m in the calcitonin group and 8 m in the placebo group (P = 0.78). At the end of the trial the ODI had improved by a mean of 3.7 points in the calcitonin group and 3.8 points in the placebo group (P = 0.44). This randomised placebo controlled trial has not shown any treatment effect in patients with lumbar spinal stenosis treated with nasal salmon calcitonin.