Effectiveness of 'Functional Range Conditioning' in Treating Patients With Chronic Non-specific Low Back Pain

NCT03456050 | Completed

• 1 other identifier: CAMS 028-3839
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are to examine the effectiveness of functional range conditioning in patients with chronic non-specific low back pain in terms of improving hip internal rotation and strength of the hip abductors, and reducing pain and disability.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Passive range of motion (Hip internal rotation)

  It will be measured using digital inclinometer

  Change from baseline passive hip internal range of motion at 8 weeks

Secondary Outcomes (3)

• Strength of the hip abductors (gluteus medius)

  Change from baseline hip abductors strength at 8 weeks

• Pain Intensitiy

  Change from baseline pain intensity at 8 weeks

• Functional disability

  Change from baseline functional disability at 8 weeks

Study Arms (2)

FRC group

EXPERIMENTAL

This group will receive FRC exercise.

Behavioral: FRC exercise

Conventional treatment

EXPERIMENTAL

This group will receive conventional exercise.

Behavioral: Conventional Exercise

Interventions

FRC exercise BEHAVIORAL

The program will consist of hip joint controlled articular rotations (CARs) in standing position for 3 - 5 repetitions. Then, the participant will sit on the floor in what is called 90/90 position which is sitting in hip and flexion in 90 degrees for both the lead (front) and trail (side) leg. The participant will perform a Progressive and regressive angular isometric loadings (PAILs and RAILs) for the trail leg to increase the range of internal rotation, the contraction will be performed three times and the holding of the position will be for two minutes. After expanding the range, the participant will perform Progressive and regressive angular loadings (PALs and RALs) isometric contractions in form of a passive range hold for internal rotation and abduction, for 3 - 5 times.

FRC group

Conventional Exercise BEHAVIORAL

The conventional training program in this study will be the routine training for increasing the hip rotation. By screening the scientific literature, the conventional training found to consists of static stretching and strengthening using body weight and/or a band and the time of holding a stretch is about 30 seconds. For that the flexibility exercise will consist of progressive stretching from a prone position (leg fall in a stretch), the participant will perform 3 - 5 repetitions with 30 seconds hold or as tolerated. The strengthening exercise consists of hip abduction (hip opening) using a band or ankle weight from side lying for 10 - 12 repetitions 3 times.

Conventional treatment

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Saudi men and women aged between 25 - 45 years with a diagnosis of chronic non-specific low back pain

You may not qualify if:

• Hip, spine and knee pathology.
• Hip and knee replacement.
• Surgery and fracture within the last 6 months.
• Cancer.
• Pregnant women.
• Any medical condition that precluded safe participation in exercise programs such as significant cardiac, pulmonary, neurological disease or mental disorder.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University

Riyāḑ, Saudi Arabia

Location

Study Officials

• ahmed alghadir, PHD

  King Saud University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Outcome provider masked about the outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate student, Principal Investigator

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 7, 2018
• Study Start: March 15, 2018
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)