Spinal Manipulation Effectiveness in Spinal Disorders

Study Overview
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Brief Summary
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The aim of the present intervention study is to determine the effectiveness of manipulation techniques.

Detailed Description
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Spinal manipulation of the spine will be assessed in patients with musculoskeletal disorders to determine the effects of different manual therapy approaches.

Official Title
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Spinal Manipulation Effectiveness in Pain, Disability and Range of Motion.

Conditions
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Low Back Pain, Cervical Pain, Pain

Intervention / Treatment
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* Other: Spinal Manipulation
* Other: Sham manipulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently suffering spinal related pain (neck, thoracic or lumbar). Not receiving additional treatment for the treated condition. Exclusion Criteria: Presence of red flags such as tumors or infection. Recent surgery. Fractures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Interventional Model Description: Single blind parallel clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal manipulation<br>Spinal manipulation to the spine will be applied to participants enrolled in this group. | Other: Spinal Manipulation<br>* Spinal manipulation based on orthopaedic manual therapy approach<br>|
| Sham Comparator: Sham manipulation<br>Sham technique wich mimic the intervention manipulation with less force and different body location will be applied. | Other: Sham manipulation<br>* Patients will receive simulated spinal manipulation without force application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogical scale | Pain was measured using a visual analogical scale (VAS). The VAS consists of a 10-cm line, with the left extremity representing (absence of pain) and the right extremity indicating (the worse pain devisable). Participants were asked to indicate in the scale their current level of pain being higher values related with more intense pain | Change from baseline to 4 weeks and 6 months of follow up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability. | Change from baseline to 4 weeks and 6 months of follow up. | 
| Range of Motion | The spinal range of motion will be assessed with a digital inclinometer which indicates the results in angular degrees. | Change from baseline to 4 weeks and 6 months of follow up. |