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Completed

NCT Number: NCT03456050

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

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Saud University

Riyāḑ, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Passive range of motion (Hip internal rotation)

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

    It will be measured using digital inclinometer

Secondary outcomes

  1. Strength of the hip abductors (gluteus medius)

    Time frame: Change from baseline hip abductors strength at 8 weeks

    Strength of the hip abductors will be measured using hand held dynamometer or isokinetic dynamometry,

  2. Pain Intensitiy

    Time frame: Change from baseline pain intensity at 8 weeks

    Pain intensity will be assessed using visual analog scale (VAS) (0 - 10 cm with 0 indicates no pain and 10 indicates the worst pain).

  3. Functional disability

    Time frame: Change from baseline functional disability at 8 weeks

    Functional disability will be assessed using Oswestry disability index. Each item in the questionnaire is scored on a 0-5 scale with zero indicating the least amount of disability and the 5 indicating most severe disability.The scores for total items answered are summed, and multiplied by two to get the index (range 0 to 100). Zero indicates no disability and 100 indicates maximum possible disability.

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 7, 2018
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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