Lower Back Myofascial Pain SyndromeNCT06138860
Effect of Strain Counter Strain Technique in Treatment of Lower Back Myofascial Pain Syndrome
A study testing strain counter strain technique and physical therapy exercises in people with Lower Back Myofascial Pain Syndrome, run by Cairo University at 1 site in Saudi Arabia.
Trial summary
This study aims to investigate the impact of impact of strain counterstrain technique on pain, lumbar range of motion and functional impairment in patients with lower back Myofascial pain syndrome. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Lower Back Myofascial Pain Syndrome
- What is being tested?
- strain counter strain technique and physical therapy exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2023to 29 Feb 2024
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patients age from 20 to 40 years for both genders.
- Patients (office worker) with mechanical back pain for 3 months ago and has not been diagnose as a specific disease or spinal abnormality.
- Patients suffering from active MTrPS in lower back muscle.
- According to the Oswestry Low Back Pain Disability Questionnaire, patients suffered moderate disability care (20-40%).
- Patients capable of doing ROM assessment of Lumbar Spine (flexion, extension, as well as side binding) within the limit of pain.
Who cannot join
- Neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor.
- Psychiatric/mental deficit.
- Patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment.
- Vertebral compression fracture
- Pregnancy and lactation.
- Existing lower limb symptoms.
- Activity intolerance due to cardiopulmonary disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Strain Counter Strain Technique in Treatment of Lower Back Myofascial Pain Syndrome: a Randomized Controlled Clinical Trial
This study aims to investigate the impact of impact of strain counterstrain technique on pain, lumbar range of motion and functional impairment in patients with lower back Myofascial pain syndrome.
Read the detailed description
Myofascial Pain Syndrome (MPS) is a prevalent form of musculoskeletal pain that impedes everyday activities and reduces productivity.Those who experience difficulties with regional pain frequently report myofascial pain. According to statistics, between 85% and 93% of patients who attend specialized pain treatment facilities and between 21% and 30% of people with regional pain who visit a general medical clinic also have it.Trigger points, which are hyperirritable tender spots in palpably tense bands of skeletal muscles, are what define it. These spots can cause referred pain patterns, painfully limited range of motion, stiffness, muscle fatigue, and autonomic dysfunction.
Numerous clinical therapies as well as training regimens have been developed to combat trigger points. Strain counterstrain technique (SCS), is one of several manual methods for trigger points, which is a passive method that opens shortened tissues and reduces musculoskeletal pain. It may be possible to activate the Golgi tendon organ, which relaxes tense and tight muscles, by positioning shortened and painful tissues in a comfortable way, which would result in a reduction in the sensitivity of the trigger point.
Hence, the purpose of this study is to ascertain how SCS affects pain, ROM, and functional disability in individuals suffering from lower back myofascial pain syndrome.
- Conditions
- Lower Back Myofascial Pain Syndrome
- Being tested
- strain counter strain technique, physical therapy exercises
- Keywords
- Low back Pain, Myofascial pain syndrome, Strain counter strain technique, trigger point
- Medical subject headings
- Low Back Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strain counter strain techniqueOther
It will be done in accordance with the technique principles in which the therapist will locate trigger point, and then find a position of comfort or mobile point (at least a 70% decrease in tenderness),monitored the tender point, holding the position o f comfort for 90 seconds, It will be conducted three times per session, for twelve sessions three times per week every other day over the course of a month.
physical therapy exercisesOther
Physical therapy exercises for twelve sessions, three times a week, over the course of a month.
Exercises will include:
stretching exercises for the hamstring, calf muscles, and back muscles.
strengthening exercises for back muscles and abdominal muscles.
| Study group | Role | What they receive |
|---|---|---|
| strain counter strain technique | Experimental | the patients will receive strain counter strain technique plus physical therapy exercises three times a week for four weeks Receives: Other: strain counter strain technique; Other: physical therapy exercises |
| physical therapy exercises | Active comparator | the patients will receive physical therapy exercise three times a week for four week Receives: Other: physical therapy exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
A Visual Analogue Scale (VAS) will be used by the patient to mark his or her level of pain, usually 10 cm long, ranging from no pain or discomfort (zero) to the worst pain that the patient can possibly feel.
Measured: up to four weeks
Secondary outcomes (2)
range of motion assessment
inclinometer will be used to assess lumbar flexion, extension and side bending
Measured: up to four weeks
functional impairment
Arabic version of Oswestry Disability Index will be used for assessment of functional disability
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back Myofascial Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Model description
- strain counter strain technique and physical therapy exercises
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- King Khalid University
- Responsible party
- Principal investigator, Doaa Ayoub Elimy Mohammed, Cairo University
- Investigators
- Ghada MR Koura, Ass. prof, Study director, King Khalid University, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138860
- Sponsor's protocol ID
- ECM#2023-1101; HAPO-06-B-001
- Status last verified
- Mar 2024
- First submitted
- 11 Nov 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strain Counter Strain Technique in Treatment of Lower Back Myofascial Pain Syndrome: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06138860
- Acronym / sponsor ID
- ECM#2023-1101; HAPO-06-B-001
- Conditions
- Lower Back Myofascial Pain Syndrome
- Keywords
- Low back Pain, Myofascial pain syndrome, Strain counter strain technique, trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- King Khalid University
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 18 Nov 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.
This study aims to investigate the impact of impact of strain counterstrain technique on pain, lumbar range of motion and functional impairment in patients with lower back Myofascial pain syndrome.
Detailed description
Myofascial Pain Syndrome (MPS) is a prevalent form of musculoskeletal pain that impedes everyday activities and reduces productivity.Those who experience difficulties with regional pain frequently report myofascial pain. According to statistics, between 85% and 93% of patients who attend specialized pain treatment facilities and between 21% and 30% of people with regional pain who visit a general medical clinic also have it.Trigger points, which are hyperirritable tender spots in palpably tense bands of skeletal muscles, are what define it. These spots can cause referred pain patterns, painfully limited range of motion, stiffness, muscle fatigue, and autonomic dysfunction.
Numerous clinical therapies as well as training regimens have been developed to combat trigger points. Strain counterstrain technique (SCS), is one of several manual methods for trigger points, which is a passive method that opens shortened tissues and reduces musculoskeletal pain. It may be possible to activate the Golgi tendon organ, which relaxes tense and tight muscles, by positioning shortened and painful tissues in a comfortable way, which would result in a reduction in the sensitivity of the trigger point.
Hence, the purpose of this study is to ascertain how SCS affects pain, ROM, and functional disability in individuals suffering from lower back myofascial pain syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- strain counter strain technique and physical therapy exercises
| Arm | Type | Receives |
|---|---|---|
| strain counter strain technique | Experimental | Other: strain counter strain technique, Other: physical therapy exercisesthe patients will receive strain counter strain technique plus physical therapy exercises three times a week for four weeks |
| physical therapy exercises | Active comparator | Other: physical therapy exercisesthe patients will receive physical therapy exercise three times a week for four week |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The patients age from 20 to 40 years for both genders.
- Patients (office worker) with mechanical back pain for 3 months ago and has not been diagnose as a specific disease or spinal abnormality.
- Patients suffering from active MTrPS in lower back muscle.
- According to the Oswestry Low Back Pain Disability Questionnaire, patients suffered moderate disability care (20-40%).
- Patients capable of doing ROM assessment of Lumbar Spine (flexion, extension, as well as side binding) within the limit of pain.
Key exclusion criteria (7 listed)
- Neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor.
- Psychiatric/mental deficit.
- Patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment.
- Vertebral compression fracture
- Pregnancy and lactation.
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 |
|---|---|---|
| strain counter strain techniqueIt will be done in accordance with the technique principles in which the therapist will locate trigger point, and then find a position of comfort or mobile point (at least a 70% decrease in tenderness),monitored the tender point, holding the position o f comfort for 90 seconds, It will be conducted three times per session, for twelve sessions three times per week every other day over the course of a month. | Other | strain counter strain technique |
| physical therapy exercisesPhysical therapy exercises for twelve sessions, three times a week, over the course of a month. Exercises will include: stretching exercises for the hamstring, calf muscles, and back muscles. strengthening exercises for back muscles and abdominal muscles. | Other | physical therapy exercises, strain counter strain technique |
Primary outcome
pain intensity
Time frame: up to four weeks
A Visual Analogue Scale (VAS) will be used by the patient to mark his or her level of pain, usually 10 cm long, ranging from no pain or discomfort (zero) to the worst pain that the patient can possibly feel.
2 secondary outcomes
range of motion assessment
Time frame: up to four weeks
functional impairment
Time frame: up to four weeks
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 5 Mar 2024.
Related trials for Lower Back Myofascial Pain Syndrome
Recruiting
Effects of Post-Isometric Relaxation and Myofascial Release on Low Back Pain With Lower Cross Syndrome
Low Back Pain, Mechanical, Lower Cross Syndrome
Recruiting
Magnetic Resonance Elastography to Monitor Response to Manual Therapy in Myofascial Pain
Myofascial Pain Syndrome - Lower Back, Myofascial Pain
Recruiting
Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome
Myofascial Pain Syndrome - Lower Back, Myofascial Pain Syndrome - Neck
Enrolling by invitationObservational study
VALIDITY AND RELIABILITY OF THE TURKISH VERSION OF THE SEX PAIN QUESTIONNAIRE
Fibromyalgia, Neck Pain Musculoskeletal
RecruitingPhase 4
Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial
Low Back Pain, Myofascial Pain Syndrome Lower Back
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.
Ghada MR Koura, Ass. prof study director
King Khalid University, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing strain counter strain technique and physical therapy exercises in people with Lower Back Myofascial Pain Syndrome, run by Cairo University at 1 site in Saudi Arabia.
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 5 inclusion and 7 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 5 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 Saudi Arabia. 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: up to four weeks). 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 5 Mar 2024.