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

NCT ID: NCT03456050

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2019-01-01

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.

Detailed Description

It will be a single blind two-arm randomized controlled trial. Saudi men and women aged between 25 - 45 years with a diagnosis of chronic non-specific low back pain will be invited to participate in this study. Subjects who will fulfill the study's criteria and who are willing to participate in this study will be asked to sign an informed consent form. The primary outcome will be the active and passive range of motion (ROM) of the hip internal rotators and it will be measured using digital inclinometer. The secondary outcomes in this study will be the maximum torque of the hip abductors (gluteus medius), concentric at a constant, low-speed, and high-speed. The peak torque and strength will be measured using isokinetic dynamometry, pain intensity will be assessed using a visual analog scale and disability will be assessed using Oswestry disability index. All participants will have their information taken by the principal investigator. Subsequently, participants will randomly be assigned to either the FRC group or the conventional treatment group by the principal investigator. Concealed randomization will be performed by means of a computer-generated table of random numbers. Outcomes will be measured at baseline, week 4 and week 8 for all participants in both groups by an assistant researcher.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

FRC group

This group will receive FRC exercise.

Group Type: EXPERIMENTAL

FRC exercise

Intervention Type: 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.

Conventional treatment

This group will receive conventional exercise.

Group Type: EXPERIMENTAL

Conventional Exercise

Intervention Type: 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.

Interventions

FRC exercise

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.

Intervention Type: BEHAVIORAL

Conventional Exercise

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Reem S. Alattallah

Post Graduate student, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ahmed alghadir, PHD

Role: STUDY_DIRECTOR

King Saud University

Locations

King Saud University

Riyāḑ, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

CAMS 028-3839

Identifier Type: -

Identifier Source: org_study_id