Clinical trial NCT05616702: Effectiveness of Pressure Biofeedback Therapy and Progressive Muscle Relaxation Technique in Improving Pain and Disability Among Patients With Non-Specific Low Back Pain
Official title: Effectiveness of Pressure Biofeedback Therapy and Progressive Muscle Relaxation Technique in Improving Pain and Disability Among Patients With Non-Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain, Mechanical
Chronic Low-back Pain
Mechanical Low Back Pain
Lower Back Pain Chronic
Low Back Pain
CLBP - Chronic Low Back Pain
Pain, Chronic
Pain, Back
Keywords: Pressure Biofeedback therapy
progressive muscles relaxation technique
chronic non-specific low back pain
chronic low back pain
non specific back pain
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain is common MSK disease with prevalence of 60 to 70 percent. Patients with low back discomfort are typically treated conservatively by physical therapists. Progressive muscles relaxation technique has been shown in several studies to reduce chronic back pain and increase flexibility. pressure biofeedback therapy works on Intra abdominal pressure.it helps to alleviate compression on lumbar spine and support the adjacent lumbar spine.The aim of this randomized controlled trial is to determine the effectiveness of pressure biofeedback training (Pr.BFB) in combination with progressive muscles relaxation technique (PMR) \& progressive muscles relaxation training alone on pain, disability, ROM \& endurance of muscles among nonspecific chronic low back pain patients.

Detailed description: A randomized clinical trial will be carried out in the Physical Therapy O.P.D of Dow hospital Karachi. Collection of data will commence right after approval of synopsis from Dow IRB. A sample of 70 NSCLBP patients calculated by using mean \& SD of visual analogue scale in abdominal stabilisation training with Pr.BFB stabilizer was 2.69 ±0.93 and Progressive muscular Relaxation VAS was 3.863 ±2.03. Before being recruited into the experiment, patients will be screened to ensure that they meet the inclusion criteria. Pain rating scale and Roland-Morris questionnaire will be used to gather data after explaining the research goals to patients and obtaining formal consent from them. Patients will be divided into 2 interventional groups by simple random sampling, with 35 patients in each group. Experimental group will be received Pressure Bio-Feedback Therapy in combination with PMR Technique and Thermotherapy. The Control group, on the other hand, will be received a combination of Progressive Muscle Relaxation Technique and Thermotherapy for non-specific CLBP. It will be a 6-weeks intervention plan with 3 sessions per week (40-minutes each). Assessor will be blinded to the treatment. Roland Morris Low back pain and disability questionnaire (RMQ) and the NPR Scale will be used as primary outcome measures. Secondary outcomes will be determined by modified-modified Schober test for assessing lumbar ROM \& Pressure Biofeedback Stabilizer unit helps to gauge muscular endurance.

Eligibility criteria: Inclusion Criteria:

* Diagnosed and referred patients with non-specific low back pain for more than 3 months
* 30 to 50 years
* Both genders

Exclusion Criteria:

* Any surgical history of lumbar spine
* Infections of the spine, malignancy
* Disc protrusion
* History of spinal fractures

Primary outcomes:
measure: Numeric Pain Rating Scale (change is being assessed)
timeFrame: Baseline and 6 weeks
measure: Roland-Morris Low Back Pain and Disability Questionnaire (change is being assessed)
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Endurance test (change is being assessed) (mmHg)
timeFrame: Baseline and 6 weeks
measure: Endurance test (change is being assessed) (hold time in seconds)
timeFrame: Baseline and 6 weeks
measure: Lumbar Range of Motion (cm) (change is being assessed)
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow Institute of Physical Medicine and Rehabilitation, DUHS.
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Farhan I Khan, Ph.D, MBA, MSc.PT, DPT
role: STUDY_DIRECTOR
References: