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Effectiveness of Pressure Biofeedback Therapy and Progressive Muscle Relaxation Technique in Improving Pain and Disability Among Patients With Non-Specific Low Back Pain

Primary Purpose

Low Back Pain, Mechanical, Chronic Low-back Pain, Mechanical Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapy
Progressive Muscles Relaxation + thermotherapy
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical focused on measuring Pressure Biofeedback therapy, progressive muscles relaxation technique, chronic non-specific low back pain, chronic low back pain, non specific back pain

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dow Institute of Physical Medicine and Rehabilitation, DUHS.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pressure Biofeedback Therapy + Progressive Muscle Relaxation Technique + Thermotherapy.

Progressive Muscle Relaxation Technique + Thermotherapy

Arm Description

This study ARM will receive following therapies Pressure Biofeedback Therapy Progressive Muscles Relaxation Technique Thermotherapy

This study ARM will receive following therapies Progressive Muscles Relaxation Technique Thermotherapy

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (change is being assessed)
On a scale of 0 to 10, "Please indicate the intensity of current, best, and worst pain levels over the past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable)"
Roland-Morris Low Back Pain and Disability Questionnaire (change is being assessed)
A standard tool called the "Roland-Morris Disability Questionnaire" consists of 24 items about a person's disabilities and pain perceptions The patient is told to draw a mark beside each element that corresponds to him or her. Sum of marked items will determine a patient's score. The scoring ranges from 0 - 24. (No to extreme disability).

Secondary Outcome Measures

Endurance test (change is being assessed) (mmHg)
For evaluating the functionality of deep abdominals via Pressure Biofeedback Unit , a standard device that monitors changes in pressure, allowing for muscle contraction and detection of spinal mobility during exercise.
Endurance test (change is being assessed) (hold time in seconds)
For evaluating the functionality of deep abdominals via Pressure Biofeedback Unit , a standard device that monitors changes in pressure, allowing for muscle contraction and detection of spinal mobility during exercise.
Lumbar Range of Motion (cm) (change is being assessed)
Modified- Modified Schober test For patients with low back discomfort, MMST method appears to be a good method for evaluating lumbar flexion and extension.

Full Information

First Posted
October 29, 2022
Last Updated
July 6, 2023
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05616702
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
October 16, 2023 (Anticipated)
Study Completion Date
November 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pressure Biofeedback Therapy + Progressive Muscle Relaxation Technique + Thermotherapy.
Arm Type
Experimental
Arm Description
This study ARM will receive following therapies Pressure Biofeedback Therapy Progressive Muscles Relaxation Technique Thermotherapy
Arm Title
Progressive Muscle Relaxation Technique + Thermotherapy
Arm Type
Active Comparator
Arm Description
This study ARM will receive following therapies Progressive Muscles Relaxation Technique Thermotherapy
Intervention Type
Other
Intervention Name(s)
Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapy
Intervention Description
Pressure Biofeedback Therapy prone position, abdominal drawing in for 10 sec. (PBU inflated to 70 mmHg) Supine position with flexed knees, abdominal drawing in for 10 sec. (PBU inflated to 40 mmHg) Progress to leg loading in supine abdominal drawing in for 10 sec. (PBU inflated to 40 mmHg) Exercising dosage: Duration: 15 mins Frequency: 3 sessions/ week Repetitions: 3 sets of 15 reps Progressive Muscles Relaxation Technique Tense => five seconds and, release => ten seconds (Each group of muscle) 2 circuits daily Exercising dosage: Duration: 15 mins Frequency: weekly 3 sessions; for 6 weeks Repetitions: 2 reps (cycles) Thermotherapy at lumbar region via electrical heating pad Duration: 15 mins
Intervention Type
Other
Intervention Name(s)
Progressive Muscles Relaxation + thermotherapy
Intervention Description
Progressive Muscles Relaxation Technique Tense => five seconds and, release => ten seconds (Each group of muscle) 2 circuits daily Exercising dosage: Duration: 15 mins Frequency: weekly 3 sessions; for 6 weeks Repetitions: 2 reps (cycles) Thermotherapy at lumbar region via electrical heating pad Duration: 15 mins
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (change is being assessed)
Description
On a scale of 0 to 10, "Please indicate the intensity of current, best, and worst pain levels over the past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable)"
Time Frame
Baseline and 6 weeks
Title
Roland-Morris Low Back Pain and Disability Questionnaire (change is being assessed)
Description
A standard tool called the "Roland-Morris Disability Questionnaire" consists of 24 items about a person's disabilities and pain perceptions The patient is told to draw a mark beside each element that corresponds to him or her. Sum of marked items will determine a patient's score. The scoring ranges from 0 - 24. (No to extreme disability).
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Endurance test (change is being assessed) (mmHg)
Description
For evaluating the functionality of deep abdominals via Pressure Biofeedback Unit , a standard device that monitors changes in pressure, allowing for muscle contraction and detection of spinal mobility during exercise.
Time Frame
Baseline and 6 weeks
Title
Endurance test (change is being assessed) (hold time in seconds)
Description
For evaluating the functionality of deep abdominals via Pressure Biofeedback Unit , a standard device that monitors changes in pressure, allowing for muscle contraction and detection of spinal mobility during exercise.
Time Frame
Baseline and 6 weeks
Title
Lumbar Range of Motion (cm) (change is being assessed)
Description
Modified- Modified Schober test For patients with low back discomfort, MMST method appears to be a good method for evaluating lumbar flexion and extension.
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaiaza Masooma, DPT
Phone
03450726077
Email
shaiazamasooma@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Farhan I Khan, Ph.D, MBA, MSc.PT, DPT
Phone
03332209704
Email
farhan.ishaque@duhs.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farhan I Khan, Ph.D, MBA, MSc.PT, DPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Dow Institute of Physical Medicine and Rehabilitation, DUHS.
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaiaza Masooma, DPT
Phone
03450726077
Email
shaiazamasooma@gmail.com
First Name & Middle Initial & Last Name & Degree
Farhan I Khan, Ph.D, MBA, MSc.PT, DPT
Phone
03332209704
Email
farhan.ishaque@duhs.edu.pk
First Name & Middle Initial & Last Name & Degree
Shaiaza Masooma, DPT

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Pressure Biofeedback Therapy and Progressive Muscle Relaxation Technique in Improving Pain and Disability Among Patients With Non-Specific Low Back Pain

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