Clinical trial NCT03456050: Effectiveness of 'Functional Range Conditioning' in Treating Patients With Chronic Non-specific Low Back Pain
Official title: Effectiveness of a New Therapeutic Technique 'Functional Range Conditioning' in Treating Patients With Chronic Non-specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 56
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Passive range of motion (Hip internal rotation)
timeFrame: Change from baseline passive hip internal range of motion at 8 weeks
Secondary outcomes:
measure: Strength of the hip abductors (gluteus medius)
timeFrame: Change from baseline hip abductors strength at 8 weeks
measure: Pain Intensitiy
timeFrame: Change from baseline pain intensity at 8 weeks
measure: Functional disability
timeFrame: Change from baseline functional disability at 8 weeks
Other outcomes:
Locations:
city: Riyad
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: ahmed alghadir, PHD
role: STUDY_DIRECTOR
References: