Spinal Manipulation Effectiveness in Spinal Disorders
1 other identifier
interventional
98
1 country
1
Brief Summary
The aim of the present intervention study is to determine the effectiveness of manipulation techniques.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable low-back-pain
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedStudy Start
First participant enrolled
February 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJune 16, 2017
June 1, 2017
2 months
February 24, 2017
June 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Oswestry Disability Index
Change from baseline to 4 weeks and 6 months of follow up.
Range of Motion
Change from baseline to 4 weeks and 6 months of follow up.
Study Arms (2)
Spinal manipulation
ACTIVE COMPARATORSpinal manipulation to the spine will be applied to participants enrolled in this group.
Sham manipulation
SHAM COMPARATORSham technique wich mimic the intervention manipulation with less force and different body location will be applied.
Interventions
Spinal manipulation based on orthopaedic manual therapy approach
Patients will receive simulated spinal manipulation without force application
Eligibility Criteria
You may qualify if:
- Currently suffering spinal related pain (neck, thoracic or lumbar).
- Not receiving additional treatment for the treated condition.
You may not qualify if:
- Presence of red flags such as tumors or infection.
- Recent surgery.
- Fractures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DAVID CRUZ DÍAZlead
Study Sites (1)
University of Jaen
Jaén, 23009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
DAVID Curz DIAZ, PhD
University of Jaen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Patients will be randomly allocated to spinal manipulation group or sham group.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Physical Therapy Department Coordinator
Study Record Dates
First Submitted
February 24, 2017
First Posted
June 16, 2017
Study Start
February 20, 2018
Primary Completion
May 1, 2018
Study Completion
November 1, 2018
Last Updated
June 16, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share
There is no intention to share the plan