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

Not Applicable
Completed
Conditions
Chronic Low Back Pain
Interventions
Behavioral: FRC exercise
Behavioral: Conventional Exercise
Registration Number
NCT03456050
Lead Sponsor
King Saud University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
56
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
FRC groupFRC exerciseThis group will receive FRC exercise.
Conventional treatmentConventional ExerciseThis group will receive conventional exercise.
Primary Outcome Measures
NameTimeMethod
Passive range of motion (Hip internal rotation)Change from baseline passive hip internal range of motion at 8 weeks

It will be measured using digital inclinometer

Secondary Outcome Measures
NameTimeMethod
Pain IntensitiyChange 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).

Strength of the hip abductors (gluteus medius)Change from baseline hip abductors strength at 8 weeks

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

Functional disabilityChange 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.

Trial Locations

Locations (1)

King Saud University

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Riyad, Saudi Arabia

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