Low Back Pain, MechanicalNCT05616702
Effectiveness of Pressure Biofeedback Therapy and Progressive Muscle Relaxation Technique in Improving Pain and Disability Among Patients With Non-Specific Low Back Pain
A study testing Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapy and Progressive Muscles Relaxation + thermotherapy in people with Low Back Pain, Mechanical and Chronic Low-back Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Low Back Pain, Mechanical, Chronic Low-back Pain, Mechanical Low Back Pain
- What is being tested?
- Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapy and Progressive Muscles Relaxation + thermotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2022to 27 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed and referred patients with non-specific low back pain for more than 3 months
- 30 to 50 years
- Both genders
Who cannot join
- Any surgical history of lumbar spine
- Infections of the spine, malignancy
- Disc protrusion
- History of spinal fractures
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Dow Institute of Physical Medicine and Rehabilitation, DUHS.
Karachi, Sindh, 74200
Shaiaza Masooma, DPT, 03450726077, shaiazamasooma@gmail.com
Farhan I Khan, Ph.D, MBA, MSc.PT, DPT, 03332209704, farhan.ishaque@duhs.edu.pk
About this study
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.
Read the 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.
- 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
- Being tested
- Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapy, Progressive Muscles Relaxation + thermotherapy
- Keywords
- Pressure Biofeedback therapy, progressive muscles relaxation technique, chronic non-specific low back pain, chronic low back pain, non specific back pain
- Medical subject headings
- Low Back Pain, Chronic Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapyOther
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
Progressive Muscles Relaxation + thermotherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Pressure Biofeedback Therapy + Progressive Muscle Relaxation Technique + Thermotherapy. | Experimental | This study ARM will receive following therapies
1. Pressure Biofeedback Therapy
2. Progressive Muscles Relaxation Technique
3. Thermotherapy Receives: Other: Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapy |
| Progressive Muscle Relaxation Technique + Thermotherapy | Active comparator | This study ARM will receive following therapies
1. Progressive Muscles Relaxation Technique
2. Thermotherapy Receives: Other: Progressive Muscles Relaxation + thermotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)"
Measured: Baseline and 6 weeks
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).
Measured: Baseline and 6 weeks
Secondary outcomes (3)
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.
Measured: Baseline and 6 weeks
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.
Measured: Baseline and 6 weeks
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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start15 Oct 2022
- Primary completion16 Oct 2023 (estimated)
- Study completion27 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaiaza Masooma, Dow University of Health Sciences
- Investigators
- Farhan I Khan, Ph.D, MBA, MSc.PT, DPT, Study director, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616702
- Sponsor's protocol ID
- 2694
- Status last verified
- Jul 2023
- First submitted
- 29 Oct 2022
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05616702
- Acronym / sponsor ID
- 2694
- 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
- Keywords
- Pressure Biofeedback therapy, progressive muscles relaxation technique, chronic non-specific low back pain, chronic low back pain, non specific back pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 16 Oct 2023 (estimated)
- Study completion
- 27 Nov 2023 (estimated)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure Biofeedback Therapy + Progressive Muscle Relaxation Technique + Thermotherapy. | Experimental | Other: Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapyThis study ARM will receive following therapies 1. Pressure Biofeedback Therapy 2. Progressive Muscles Relaxation Technique 3. Thermotherapy |
| Progressive Muscle Relaxation Technique + Thermotherapy | Active comparator | Other: Progressive Muscles Relaxation + thermotherapyThis study ARM will receive following therapies 1. Progressive Muscles Relaxation Technique 2. Thermotherapy |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed and referred patients with non-specific low back pain for more than 3 months
- 30 to 50 years
- Both genders
Key exclusion criteria (4 listed)
- Any surgical history of lumbar spine
- Infections of the spine, malignancy
- Disc protrusion
- History of spinal fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapyPressure 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 | Other | Pressure Biofeedback Therapy + Progressive Muscle Relaxation Technique + Thermotherapy. |
| Progressive Muscles Relaxation + thermotherapyProgressive 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 | Other | Progressive Muscle Relaxation Technique + Thermotherapy |
Primary outcome
Numeric Pain Rating Scale (change is being assessed)
Time frame: Baseline and 6 weeks
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)
Time frame: Baseline and 6 weeks
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).
3 secondary outcomes
Endurance test (change is being assessed) (mmHg)
Time frame: Baseline and 6 weeks
Endurance test (change is being assessed) (hold time in seconds)
Time frame: Baseline and 6 weeks
Lumbar Range of Motion (cm) (change is being assessed)
Time frame: Baseline and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain, Mechanical
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain
Low Back Pain, Dry Needling
Recruiting
Fusion or Not - a Study on Low Back Pain
Low Back Pain, Mechanical, Degenerative Disc Disease Lumbar
Recruiting
Effects of Post-Isometric Relaxation and Myofascial Release on Low Back Pain With Lower Cross Syndrome
Low Back Pain, Mechanical, Lower Cross Syndrome
RecruitingPhase 1
Adia Med of Winter Park LLC Lower Back Pain Research Study
Chronic Mechanical Lower Back Pain, Lower Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farhan I Khan, Ph.D, MBA, MSc.PT, DPT study director
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure Biofeedback Therapy + Progressive Muscles Relaxation + thermotherapy and Progressive Muscles Relaxation + thermotherapy in people with Low Back Pain, Mechanical and Chronic Low-back Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaiaza Masooma, DPT (03450726077, shaiazamasooma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (change is being assessed) (time frame: Baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.