Specific or Non-Specific Manipulation for Patients With Back Pain

Study Overview
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Brief Summary
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We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.

Detailed Description
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To evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization. 148 patients with chronic non-specific low back pain will be enrolled for this clinical trial. Patients will undergo to a specific physical examination in order to determine the ideal lumbar spine level to be manipulated. The outcomes of interest are pain intensity, pain pressure threshold, global perceived effect and disability associated with back pain. After the first assessment patients will be randomly assigned to two groups that will receive 10 sessions of spinal manipulation over a period of four weeks, and may receive manipulation according to the findings on physical examination (specific manipulation) or may receive manipulation in the upper thoracic region, disregarding the physical examination findings (nonspecific manipulation).

Official Title
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Short, Medium and Long Term Effects of Specific and Nonspecific Spinal Manipulative Therapy in Patients With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Specific manipulation
* Other: Non-specific manipulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients with low back pain duration from 3 to 24 months. Exclusion criteria: Patients with a pain duration lower than 3 months and higher than 24 months. Patients with nerve root compromise or with serious spinal pathology, Pregnant patients, Previous back surgery Patients with any contra-indication to spinal manipulation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: specific manipulation<br>Participants allocated to group specific manipulation, will have their lumbar spine manipulated according to the previous clinical examination. | Other: Specific manipulation<br>* Patients allocated to the specific manipulation group will receive spinal manipulation according to the physical examination performed prior to the treatment allocation.<br>|
| Experimental: non-specific manipulation<br>Participants allocated to group non-specific manipulation will have their upper thoracic spine manipulated (also known as global manipulation) regardless of the previous clinical examination. | Other: Non-specific manipulation<br>* Patients allocated to the specific manipulation group will receive spinal manipulation on the upper thoracic spine that will be not related to the physical examination performed prior to the treatment allocation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Pain intensity will be measured using a 0-10 numerical rating scale | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Pain intensity will be measured using a 0-10 numerical rating scale | 3 and 6 months after randomization | 
| Disability | Disability will be measured by the 0-24 Roland Morris Disability Questionnaire | 4 weeks, 3 and 6 months after randomization | 
| Global Impression of Recovery | Global impression of recovery will be measured by an 11-item Global Perceived Effect Scale | 4 weeks, 3 and 6 months after randomization | 
| Pressure Pain Threshold | Pressure Pain Threshold will be measure by a digital pressure algomoter | 4 weeks after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back pain, spinal manipulation