Back to resultsSpinal Manipulation Effectiveness in Spinal Disorders
Primary Purpose
Low Back Pain, Cervical Pain, Pain
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Spinal Manipulation
Sham manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
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.
Sites / Locations
- University of Jaen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Spinal manipulation
Sham manipulation
Arm Description
Spinal manipulation to the spine will be applied to participants enrolled in this group.
Sham technique wich mimic the intervention manipulation with less force and different body location will be applied.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Range of Motion
The spinal range of motion will be assessed with a digital inclinometer which indicates the results in angular degrees.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03190187
Brief Title
Spinal Manipulation Effectiveness in Spinal Disorders
Official Title
Spinal Manipulation Effectiveness in Pain, Disability and Range of Motion.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2018 (Anticipated)
Primary Completion Date
May 1, 2018 (Anticipated)
Study Completion Date
November 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
DAVID CRUZ DÍAZ
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present intervention study is to determine the effectiveness of manipulation techniques.
Detailed Description
Spinal manipulation of the spine will be assessed in patients with musculoskeletal disorders to determine the effects of different manual therapy approaches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Cervical Pain, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind parallel clinical trial
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Patients will be randomly allocated to spinal manipulation group or sham group.
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spinal manipulation
Arm Type
Active Comparator
Arm Description
Spinal manipulation to the spine will be applied to participants enrolled in this group.
Arm Title
Sham manipulation
Arm Type
Sham Comparator
Arm Description
Sham technique wich mimic the intervention manipulation with less force and different body location will be applied.
Intervention Type
Other
Intervention Name(s)
Spinal Manipulation
Intervention Description
Spinal manipulation based on orthopaedic manual therapy approach
Intervention Type
Other
Intervention Name(s)
Sham manipulation
Intervention Description
Patients will receive simulated spinal manipulation without force application
Primary Outcome Measure Information:
Title
Visual analogical scale
Description
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
Time Frame
Change from baseline to 4 weeks and 6 months of follow up.
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
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.
Time Frame
Change from baseline to 4 weeks and 6 months of follow up.
Title
Range of Motion
Description
The spinal range of motion will be assessed with a digital inclinometer which indicates the results in angular degrees.
Time Frame
Change from baseline to 4 weeks and 6 months of follow up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Amat, PhD
Phone
+34953212121
Email
amamat@ujaen.es
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Gonzalez, PhD
Phone
+3495312336
Email
mgsanche@ujaen.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DAVID Curz DIAZ, PhD
Organizational Affiliation
University of Jaen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Jaen
City
Jaen
ZIP/Postal Code
23009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no intention to share the plan
Learn more about this trial
Spinal Manipulation Effectiveness in Spinal Disorders
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