LordosisNCT05428280
Comparing the Effects of Muscle Energy Technique Versus Myofascial Mobilization in Managing Sub-acute Low Back Pain
A study testing Physiotherapy, Muscle Energy technique and Myofacial mobilization in people with Lordosis and Low Back Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Institute for Clinical Systems Improvement (ICSI) defines sub-acute low back pain as low back pain lasting between 4 and 12 weeks. There is insufficient evidence regarding the comparative effect of muscle energy technique and myofascial mobilization in the management of sub-acute non-specific low back pain with the… Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Lordosis, Low Back Pain
- What is being tested?
- Physiotherapy, Muscle Energy technique and Myofacial mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Dec 2021to 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sub-acute low back pain with the range of 7 to 12 weeks of unresolved symptoms.
- Positive test of tight Erector spinae muscle and Tight Quadratus Lumboram muscle
Who cannot join
- Spinal malignancy
- Spinal fracture
- Spine foraminal stenosis
- Nerve root compression
- Radicular symptoms
- Sciatica
Show all 13Show fewer
- Cord compression
- Paralysis
- Muscular dystrophy
- Myelopathy
- Seizure disorder
- Severe trauma
- Unexplained weight loss
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sindh Institute of Physical Medicine and Rehabilitation
Karachi, Sindh, 74200
About this study
Official title: Effectiveness of Muscle Energy Technique Versus Myofascial Mobilization in Improving Functional Outcome in Sub-acute Non-specific Low Back Pain: A Randomized Controlled Trial
Institute for Clinical Systems Improvement (ICSI) defines sub-acute low back pain as low back pain lasting between 4 and 12 weeks. There is insufficient evidence regarding the comparative effect of muscle energy technique and myofascial mobilization in the management of sub-acute non-specific low back pain with the tightness of quadratus lumborum and erector spinae muscles
Read the detailed description
A randomized experimental controlled trial will be carried out to compare the effectiveness of muscle energy technique and myofascial mobilization in the management of sub-acute non-specific low back pain. A total of 60 male and female volunteers having subjects with sub-acute nonspecific low back pain will be recruited in this study. Subjects will be assessed at baseline for pain and disability using Visual Analogue Scale and Ronald Morris Disability Questionnaire (RMDQ 0-24) respectively. After baseline assessment, all subjects will be allocated to two groups through computer-generated random sampling. Group 1 will perform Muscle energy technique combined with conventional exercise; Group 2 will receive Myofascial Mobilization combined with conventional exercise. This study will be conducted at the Physiotherapy Department of Sindh Institute of Physical Medicine and Rehabilitation (SIPM\&R). Data will be analyzed using SPSS 21 and ANCOVA technique will be used in this study.
- Conditions
- Lordosis, Low Back Pain
- Being tested
- Physiotherapy, Muscle Energy technique, Myofacial mobilization
- Medical subject headings
- Lordosis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Conventional treatment consisted of Transcutaneous Electrical Nerve Stimulation and Progressive Back Strengthening Exercise
Muscle Energy techniqueOther
Muscle Energy Technique (MET) is a technique that was developed in 1948 by Fred Mitchell, Sr, D.O[1]. It is a form of manual therapy, widely used in Osteopathy, that uses a muscle's own energy in the form of gentle isometric contractions to relax the muscles via autogenic or reciprocal inhibition and lengthen the muscle.
Myofacial mobilizationOther
It is a type of gentle, constant massage that releases tightness and pain throughout your myofascial tissues
| Study group | Role | What they receive |
|---|---|---|
| Muscle Energy Techniques | Experimental | Following physiotherapy will be given to the participants in this group for 4 weeks, 3 times a week:
1. Muscle Energy Technique Receives: Other: Physiotherapy; Other: Muscle Energy technique |
| Myofascial Mobilization Techniques | Active comparator | Following physiotherapy will be given to the participants in this group for 4 weeks, 3 times a week:
1. Myofascial Mobilization Receives: Other: Physiotherapy; Other: Myofacial mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The visual analogue scale is used for measurement of pain intensity. It is a continuous scale. It comprises a horizontal or vertical 10 centimeters or 100 millimeters line. The participant is asked to indicate a point of pain intensity by placing a line perpendicular to the Visual analogue scale line. The scale is most commonly referred by "no pain" with score of 0 and "worst imaginable pain" with score of 100 on the scale. The higher scores shows higher pain intensity and lower scores shows lower pain intensity.
Measured: Change from baseline pain intensity at 4 weeks
Rolland Morris Disability Questionnaire
It is a standard questionnaire with questions regarding pain and the disabling effect on daily activities. Its score ranges from 0 to 24 (no disability to maximum disability)
Measured: Change from baseline functional disability at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start22 Dec 2021
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LordosisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faizan Abdullah, Dow University of Health Sciences
- Investigators
- Faizan Abdullah, MSAPT, DPT, Principal investigator, Sindh Institute of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428280
- Sponsor's protocol ID
- FAbdullah
- Status last verified
- Mar 2024
- First submitted
- 13 Jun 2022
- Last updated
- 27 Mar 2024
- 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Muscle Energy Technique Versus Myofascial Mobilization in Improving Functional Outcome in Sub-acute Non-specific Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05428280
- Acronym / sponsor ID
- FAbdullah
- Conditions
- Lordosis, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 23 Jun 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.
Institute for Clinical Systems Improvement (ICSI) defines sub-acute low back pain as low back pain lasting between 4 and 12 weeks. There is insufficient evidence regarding the comparative effect of muscle energy technique and myofascial mobilization in the management of sub-acute non-specific low back pain with the tightness of quadratus lumborum and erector spinae muscles
Detailed description
A randomized experimental controlled trial will be carried out to compare the effectiveness of muscle energy technique and myofascial mobilization in the management of sub-acute non-specific low back pain. A total of 60 male and female volunteers having subjects with sub-acute nonspecific low back pain will be recruited in this study. Subjects will be assessed at baseline for pain and disability using Visual Analogue Scale and Ronald Morris Disability Questionnaire (RMDQ 0-24) respectively. After baseline assessment, all subjects will be allocated to two groups through computer-generated random sampling. Group 1 will perform Muscle energy technique combined with conventional exercise; Group 2 will receive Myofascial Mobilization combined with conventional exercise. This study will be conducted at the Physiotherapy Department of Sindh Institute of Physical Medicine and Rehabilitation (SIPM\&R). Data will be analyzed using SPSS 21 and ANCOVA technique will be used in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle Energy Techniques | Experimental | Other: Physiotherapy, Other: Muscle Energy techniqueFollowing physiotherapy will be given to the participants in this group for 4 weeks, 3 times a week: 1. Muscle Energy Technique |
| Myofascial Mobilization Techniques | Active comparator | Other: Physiotherapy, Other: Myofacial mobilizationFollowing physiotherapy will be given to the participants in this group for 4 weeks, 3 times a week: 1. Myofascial Mobilization |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sub-acute low back pain with the range of 7 to 12 weeks of unresolved symptoms.
- Positive test of tight Erector spinae muscle and Tight Quadratus Lumboram muscle
Key exclusion criteria (13 listed)
- Spinal malignancy
- Spinal fracture
- Spine foraminal stenosis
- Nerve root compression
- Radicular symptoms
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 |
|---|---|---|
| PhysiotherapyConventional treatment consisted of Transcutaneous Electrical Nerve Stimulation and Progressive Back Strengthening Exercise | Other | Muscle Energy Techniques, Myofascial Mobilization Techniques |
| Muscle Energy techniqueMuscle Energy Technique (MET) is a technique that was developed in 1948 by Fred Mitchell, Sr, D.O[1]. It is a form of manual therapy, widely used in Osteopathy, that uses a muscle's own energy in the form of gentle isometric contractions to relax the muscles via autogenic or reciprocal inhibition and lengthen the muscle. | Other | Muscle Energy Techniques |
| Myofacial mobilizationIt is a type of gentle, constant massage that releases tightness and pain throughout your myofascial tissues | Other | Myofascial Mobilization Techniques |
Primary outcome
Visual Analogue Scale
Time frame: Change from baseline pain intensity at 4 weeks
The visual analogue scale is used for measurement of pain intensity. It is a continuous scale. It comprises a horizontal or vertical 10 centimeters or 100 millimeters line. The participant is asked to indicate a point of pain intensity by placing a line perpendicular to the Visual analogue scale line. The scale is most commonly referred by "no pain" with score of 0 and "worst imaginable pain" with score of 100 on the scale. The higher scores shows higher pain intensity and lower scores shows lower pain intensity.
Rolland Morris Disability Questionnaire
Time frame: Change from baseline functional disability at 4 weeks
It is a standard questionnaire with questions regarding pain and the disabling effect on daily activities. Its score ranges from 0 to 24 (no disability to maximum disability)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No
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Longitudinal Changes in Spinopelvic Alignment and Sagittal Balance After Bariatric Surgery in Patients With Morbid Obesity: A Prospective Observational Study
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Egoscue and Core Stabilization for Chronic Low Back Pain
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Hamstring Tightness and Lumbar Lordosis Angel Across Functional Sitting Posture.
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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.
Faizan Abdullah, MSAPT, DPT principal investigator
Sindh Institute of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy, Muscle Energy technique and Myofacial mobilization in people with Lordosis and 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 2 inclusion and 13 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: finished, as of the sponsor's last update on 27 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Change from baseline pain intensity at 4 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 27 Mar 2024.