Lumbar Pain SyndromeNCT05785104
Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain
A study testing Myofascial release and Muscle energy technique in people with Lumbar Pain Syndrome and Cervical Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to determine the effect of muscle energy technique versus myofascial release on cervical and lumbar pain in premenopausal women with fibromyalgia Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- Lumbar Pain Syndrome, Cervical Pain
- What is being tested?
- Myofascial release and Muscle energy technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 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 30 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women with fibromyalgia
- Ages ranges between 30 - 45 years old
- Body mass index < 35 kg/m2
- All are medically stable
Who cannot join
- specific cervical and lumbar pain
- Smokers
- Pregnant women
- Medically unstable
- Postmenopausal women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain in Premenopausal Women With Fibromyalgia
The aim of the study is to determine the effect of muscle energy technique versus myofascial release on cervical and lumbar pain in premenopausal women with fibromyalgia
Read the detailed description
Fibromyalgia is an idiopathic, non articular pain syndrome with generalized tender points. It is multisystem disease characterized by sleep disturbance and fatigue. It affect 5% of the world population. The incidence is higher in women than in men. And the age is between 30 and 35 years old.
- Conditions
- Lumbar Pain Syndrome, Cervical Pain
- Being tested
- Myofascial release, Muscle energy technique
- Keywords
- Cervical pain,lumbar pain,fibromyalgia
- Medical subject headings
- Somatoform Disorders, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial releaseOther
Is Facilitation of mechanical and neurological adaptive capacity as integrated through the Myofascial system
Muscle energy techniqueOther
Is manual therapy procedure that involves alternating periods of resisted muscle contraction and assisted stretching
| Study group | Role | What they receive |
|---|---|---|
| Myofascial release | Experimental | The patients will receive myofascial release technique on cervical and lumbar regions three times per week for four weeks Receives: Other: Myofascial release |
| Muscle energy technique | Experimental | The patients will receive muscle energy technique for cervical and lumbar regions three times per week for four weeks Receives: Other: Muscle energy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia impact questionnaire
Used to assess health related quality of life before and after the treatment, maximum score means worse outcome
Measured: Four weeks
Visual analogue scale
Used to assess the severity of cervical and lumbar pain of each premenopausal women in both groups before and after the treatment, maximum score means worse outcome
Measured: Four weeks
Active range of motion of cervical and lumbar regions
Measurement of active flexion, extension, lateral flexion in cervical and lumbar regions before and after the treatment
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 May 2023
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar 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
- Two groups, one group will be treated by muscle energy technique and other will be treated by myofascial release
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Ahmed Abd EL Salam Negm, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785104
- Sponsor's protocol ID
- 012/004046
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain in Premenopausal Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT05785104
- Acronym / sponsor ID
- 012/004046
- Conditions
- Lumbar Pain Syndrome, Cervical Pain
- Keywords
- Cervical pain,lumbar pain,fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 27 Mar 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.
The aim of the study is to determine the effect of muscle energy technique versus myofascial release on cervical and lumbar pain in premenopausal women with fibromyalgia
Detailed description
Fibromyalgia is an idiopathic, non articular pain syndrome with generalized tender points. It is multisystem disease characterized by sleep disturbance and fatigue. It affect 5% of the world population. The incidence is higher in women than in men. And the age is between 30 and 35 years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups, one group will be treated by muscle energy technique and other will be treated by myofascial release
| Arm | Type | Receives |
|---|---|---|
| Myofascial release | Experimental | Other: Myofascial releaseThe patients will receive myofascial release technique on cervical and lumbar regions three times per week for four weeks |
| Muscle energy technique | Experimental | Other: Muscle energy techniqueThe patients will receive muscle energy technique for cervical and lumbar regions three times per week for four weeks |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Premenopausal women with fibromyalgia
- Ages ranges between 30 - 45 years old
- Body mass index < 35 kg/m2
- All are medically stable
Key exclusion criteria (5 listed)
- specific cervical and lumbar pain
- Smokers
- Pregnant women
- Medically unstable
- Postmenopausal women
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 |
|---|---|---|
| Myofascial releaseIs Facilitation of mechanical and neurological adaptive capacity as integrated through the Myofascial system | Other | Myofascial release |
| Muscle energy techniqueIs manual therapy procedure that involves alternating periods of resisted muscle contraction and assisted stretching | Other | Muscle energy technique |
Primary outcome
Fibromyalgia impact questionnaire
Time frame: Four weeks
Used to assess health related quality of life before and after the treatment, maximum score means worse outcome
Visual analogue scale
Time frame: Four weeks
Used to assess the severity of cervical and lumbar pain of each premenopausal women in both groups before and after the treatment, maximum score means worse outcome
Active range of motion of cervical and lumbar regions
Time frame: Four weeks
Measurement of active flexion, extension, lateral flexion in cervical and lumbar regions before and after the treatment
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 6 Mar 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial release and Muscle energy technique in people with Lumbar Pain Syndrome and Cervical Pain, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 5 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 6 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 Egypt. 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?
Fibromyalgia impact questionnaire (time frame: Four weeks). The study lists 3 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 6 Mar 2024.