Spinal Manipulation Effectiveness in Spinal Disorders

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03190187
• Other study ID #: ManipulationUja
• Status: Not yet recruiting
• Phase: N/A
• First received: February 24, 2017
• Last updated: June 15, 2017
• Start date: February 20, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: June 2017
• Source: University of Jaén
• Contact: Antonio Amat, PhD
• Phone: +34953212121
• Email: amamat[@]ujaen.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present intervention study is to determine the effectiveness of manipulation techniques.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: November 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Cervical Pain
• Low Back Pain
• Neck Pain
• Pain

Intervention

Other:
• Spinal Manipulation
Spinal manipulation based on orthopaedic manual therapy approach
• Sham manipulation
Patients will receive simulated spinal manipulation without force application

Locations

Country	Name	City	State
Spain	University of Jaen	Jaen

Sponsors (1)

Lead Sponsor	Collaborator
DAVID CRUZ DÍAZ

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.