Low Back Pain, MechanicalNCT05939024
Efficacy of Muscle Energy Techniques in the Treatment of Chronic Non-specific Low Back Pain
A study testing Muscle Energy Technique plus Conventional Physical Therapy and Conventional Physical Therapy in people with Low Back Pain, Mechanical, run by University of Lahore at 1 site in Pakistan.
Trial summary
Chronic Non-Specific Low Back Pain is characterized as a tension, soreness and stiffness. Various studies, defined MET as a manual medicine treatment procedure that involves the voluntary contraction of the subject's muscle in a precisely controlled direction, at varying levels of intensity, against a distinctly… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Muscle Energy Technique plus Conventional Physical Therapy and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2022to 31 Jul 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 - 45 years
- Gender : both genders
- Low Back Pain of more than 3 months duration
- ODI Score between 20-80%
- BMI: 25-29 Kg/m2
- VAS: Initial Pain Score > 3
- Pain Localized to Lower Lumbar Region
- Decreased Lumbar ROM
Who cannot join
- Red Flag Signs of Low Back Pain (Metabolic Bone Disease, Malignancy, Cardiovascular Disorder, Pregnancy)
- Patient with Paraesthesia or Numbness
- Disturbed Reflexes (Hypo/Hyper Reflexia)
- Motor Weakness
- H/O Low Back Surgery
- H/O Recent Trauma < 2 Months
Show all 9Show fewer
- H/O Rheumatoid Arthritis, Osteoporosis and Fracture
- Joint hyper mobility.
- Psychological Mental Disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Conventional Physical Therapy With and Without Muscle Energy Techniques in the Treatment of Chronic Non-Specific Low Back Pain
Chronic Non-Specific Low Back Pain is characterized as a tension, soreness and stiffness. Various studies, defined MET as a manual medicine treatment procedure that involves the voluntary contraction of the subject's muscle in a precisely controlled direction, at varying levels of intensity, against a distinctly executed counterforce applied by the therapist.
Read the detailed description
Chronic Non-specific LBP is located in region below lower costal margins and above inferior gluteal margins with or without any referred pain in legs, an essentially non-attributable to any specific cause. It may lasting for more than 7-12 months and affect individual over a long period of time once in a lifetime at least. METs is useful in increasing extensibility and range of motion of various joints and provides good results in the patients with back pain. These techniques are used as the treatment of weakened muscles, restricted joints, reducing pain reliving muscle tension \& spasm, \& increased strength of the muscle. MET is a verstile, safe, gentle technique traditionally used to address muscular strain, PAIN, local edema and joint dysfunction. It was reported that post isometric relaxation is considered a highly effective therapy for back dysfunction patients.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Muscle Energy Technique plus Conventional Physical Therapy, Conventional Physical Therapy
- Keywords
- Muscle Energy Technique, Physical Therapy, Pain, Functional Disability, Fear Avoidance Beliefs, Quality of Life, Range of Motion
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Energy Technique plus Conventional Physical TherapyOther
Also called Post-Isometric Relaxation Technique plus Conventional Physical Therapy
Post-Isometric Relaxation of the Muscle Energy Techniques will be applied to Spinal Stabilizers and Mechanoreceptors. Hold time will be 7 seconds with 5 seconds rest between two performance x 3 times /session. Whereas, Conventional Physical Therapy consists of hot pack, TENS, Ultrasonic along with stretching and exercises of back musculature.
Conventional Physical TherapyOther
Conventional Physical Therapy consists of hot pack, TENS, Ultrasonic along with stretching and exercises of back musculature.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physical Therapy (CPT) Group | Active comparator | Patients in this group will receive Conventional Physical therapy only, which includes hot pack, TENS, Ultrasonic, stretching and strengthening exercises. Receives: Other: Conventional Physical Therapy |
| Muscle Energy Technique plus Conventional Physical Therapy Group | Experimental | In this group, Post Isometric Relaxation of the Muscle Energy Techniques will be applied to the Spinal Stabilizers and Mechanoreceptors in addition to Conventional Physical Therapy. Receives: Other: Muscle Energy Technique plus Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be measured using Visual Analogue Scale. It consists of a 10cm line, with two end points, 0 representing no pain and 10 representing pain as bad as it could be possible.
Measured: Pain intensity will be measured at the baseline at the time of recruitment, and change in pain intensity will be measured at 2nd week and 3rd week of intervention.
Lumbar Ranges of Motion
Lumbar Ranges of Motion will be measured using inclinometer. The normal amount of lumbar flexion range of motion is 60 degrees, and the normal range of motion of lumbar extension is 25 degrees. The lumbar spine also normally moves 25 degrees in lateral flexion, or side bending.
Measured: Lumbar Range of Motion will be measured at baseline at the time of recruitment and change in range of motion will be measured at 2nd week and 3rd week of treatment.
Functional Disability Level
Oswestry Disability Index was used to determine the functional status of individual. The final score ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Measured: Level of Functional Disability will be recorded as baseline at the time of recruitment and change in functional status will be observed at the 2nd week and 3rd week of intervention.
Change in Fear Avoidance Belief
Fear Avoidance Beliefs will be observed using Fear Avoidance Beliefs Questionnaire. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
Measured: Fear Avoidance Beliefs will be observed as baseline at the time of recruitment and any change in Fear Avoidance Beliefs will be observed at the 2nd week and 3rd week of treatment.
Change in Quality of Life
Short Form-36 Health Survey Questionnaire was used to measure change in Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Total score of this questionnaire is 100, with lower the score the more disability, the higher the score the less disability.
Measured: Change in quality of life will be measured at baseline at the time of recruitment and change in quality of life will be measured at the 2nd week and 3rd week of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Feb 2022
- Primary completion15 Jul 2023
- Study completion31 Jul 2023
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.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Jamil, University of Lahore
- Investigators
- Prof. Dr Ashfaq Ahmed, PhD, Study chair, University of LahoreRashid Hafeez Nasir, M. Phil, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939024
- Sponsor's protocol ID
- Rashid
- Status last verified
- Aug 2023
- First submitted
- 20 Jun 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants data that underlies the results after de-identification
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Conventional Physical Therapy With and Without Muscle Energy Techniques in the Treatment of Chronic Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05939024
- Acronym / sponsor ID
- Rashid
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Muscle Energy Technique, Physical Therapy, Pain, Functional Disability, Fear Avoidance Beliefs, Quality of Life, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 11 Jul 2023 (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.
Chronic Non-Specific Low Back Pain is characterized as a tension, soreness and stiffness. Various studies, defined MET as a manual medicine treatment procedure that involves the voluntary contraction of the subject's muscle in a precisely controlled direction, at varying levels of intensity, against a distinctly executed counterforce applied by the therapist.
Detailed description
Chronic Non-specific LBP is located in region below lower costal margins and above inferior gluteal margins with or without any referred pain in legs, an essentially non-attributable to any specific cause. It may lasting for more than 7-12 months and affect individual over a long period of time once in a lifetime at least. METs is useful in increasing extensibility and range of motion of various joints and provides good results in the patients with back pain. These techniques are used as the treatment of weakened muscles, restricted joints, reducing pain reliving muscle tension \& spasm, \& increased strength of the muscle. MET is a verstile, safe, gentle technique traditionally used to address muscular strain, PAIN, local edema and joint dysfunction. It was reported that post isometric relaxation is considered a highly effective therapy for back dysfunction patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Physical Therapy (CPT) Group | Active comparator | Other: Conventional Physical TherapyPatients in this group will receive Conventional Physical therapy only, which includes hot pack, TENS, Ultrasonic, stretching and strengthening exercises. |
| Muscle Energy Technique plus Conventional Physical Therapy Group | Experimental | Other: Muscle Energy Technique plus Conventional Physical TherapyIn this group, Post Isometric Relaxation of the Muscle Energy Techniques will be applied to the Spinal Stabilizers and Mechanoreceptors in addition to Conventional Physical Therapy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 18 - 45 years
- Gender : both genders
- Low Back Pain of more than 3 months duration
- ODI Score between 20-80%
- BMI: 25-29 Kg/m2
Key exclusion criteria (9 listed)
- Red Flag Signs of Low Back Pain (Metabolic Bone Disease, Malignancy, Cardiovascular Disorder, Pregnancy)
- Patient with Paraesthesia or Numbness
- Disturbed Reflexes (Hypo/Hyper Reflexia)
- Motor Weakness
- H/O Low Back Surgery
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 |
|---|---|---|
| Muscle Energy Technique plus Conventional Physical TherapyAlso: Post-Isometric Relaxation Technique plus Conventional Physical TherapyPost-Isometric Relaxation of the Muscle Energy Techniques will be applied to Spinal Stabilizers and Mechanoreceptors. Hold time will be 7 seconds with 5 seconds rest between two performance x 3 times /session. Whereas, Conventional Physical Therapy consists of hot pack, TENS, Ultrasonic along with stretching and exercises of back musculature. | Other | Muscle Energy Technique plus Conventional Physical Therapy Group |
| Conventional Physical TherapyConventional Physical Therapy consists of hot pack, TENS, Ultrasonic along with stretching and exercises of back musculature. | Other | Conventional Physical Therapy (CPT) Group |
Primary outcome
Pain Intensity
Time frame: Pain intensity will be measured at the baseline at the time of recruitment, and change in pain intensity will be measured at 2nd week and 3rd week of intervention.
Pain intensity will be measured using Visual Analogue Scale. It consists of a 10cm line, with two end points, 0 representing no pain and 10 representing pain as bad as it could be possible.
Lumbar Ranges of Motion
Time frame: Lumbar Range of Motion will be measured at baseline at the time of recruitment and change in range of motion will be measured at 2nd week and 3rd week of treatment.
Lumbar Ranges of Motion will be measured using inclinometer. The normal amount of lumbar flexion range of motion is 60 degrees, and the normal range of motion of lumbar extension is 25 degrees. The lumbar spine also normally moves 25 degrees in lateral flexion, or side bending.
Functional Disability Level
Time frame: Level of Functional Disability will be recorded as baseline at the time of recruitment and change in functional status will be observed at the 2nd week and 3rd week of intervention.
Oswestry Disability Index was used to determine the functional status of individual. The final score ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Change in Fear Avoidance Belief
Time frame: Fear Avoidance Beliefs will be observed as baseline at the time of recruitment and any change in Fear Avoidance Beliefs will be observed at the 2nd week and 3rd week of treatment.
Fear Avoidance Beliefs will be observed using Fear Avoidance Beliefs Questionnaire. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.
Change in Quality of Life
Time frame: Change in quality of life will be measured at baseline at the time of recruitment and change in quality of life will be measured at the 2nd week and 3rd week of intervention.
Short Form-36 Health Survey Questionnaire was used to measure change in Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Total score of this questionnaire is 100, with lower the score the more disability, the higher the score the less 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 16 Aug 2023.
- Individual participant dataSharing planned: Yes. Participants data that underlies the results after de-identification
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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.
Prof. Dr Ashfaq Ahmed, PhD study chair
University of Lahore
Rashid Hafeez Nasir, M. Phil principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Energy Technique plus Conventional Physical Therapy and Conventional Physical Therapy in people with Low Back Pain, Mechanical, run by University of Lahore 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 8 inclusion and 9 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 16 Aug 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?
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?
Pain Intensity (time frame: Pain intensity will be measured at the baseline at the time of recruitment, and change in pain intensity will be measured at 2nd week and 3rd week of intervention.). The study lists 5 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 16 Aug 2023.