Low Back PainNCT05680493
Comparison of Dry Needling and Manual Pressure Release for Managing Low Back Pain
A study testing Manual pressure release, Dry needling and Heat therapy in people with Low Back Pain, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This study will compare the effect of dry needling and manual pressure in patients having low back pain in terms of pain and disability. There will be two groups ; experimental and control. Half of study group will receive dry needling session along with hot pack. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Manual pressure release, Dry needling and Heat therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2022to 1 Feb 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 30-60
- pateint with subacute and chronic low back pain at least last 6 months.
- pateint with active MTrps.
Who cannot join
- patient with fibromyalgia
- pregnant females
- patient with chronic diseases (osteoporosis, lungs disease and diabetes)
- patient with musculoskeletal injuries
- patient that are using any medication to relief pain like analgesic or muscle relaxants
- Any treatment for back pain in same period of research.
- patient having any radiculopathies or discogenic low back pain
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
About this study
This study will compare the effect of dry needling and manual pressure in patients having low back pain in terms of pain and disability. There will be two groups ; experimental and control. Half of study group will receive dry needling session along with hot pack. Half of study group will receive manual pressure technique along with hot pack.
Read the detailed description
The study is Randomized Control Trail , which is being conducted in fauji foundation hospital and Foundation University College Of Rehabilitation (oct 2022-feb 2023) . Sample size of 50 individual was calculated using epitool with 95% confidence interval (CI), and power 80%. sample will be collected through pilot study .
both groups will recieve conventional physiotherapy protocol (hot pack) Assessment will be done on baseline, and 4th week .
- Conditions
- Low Back Pain
- Being tested
- Manual pressure release, Dry needling, Heat therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual pressure releaseProcedure or surgery
lengthens the muscle up to the increasing resistance, then gradually applies gentle pressure on MTrp until fingers feels a definite increase in tissue resistance (first barrier). Pressure would maintain until clinician sense relief of tension
Dry needlingProcedure or surgery
A filiform needle is inserted at 45 degree in to trigger point and then twirl the needle up and down to release trigger point
Heat therapyProcedure or surgery
Hydro collator pack will be placed on affected area for relaxation and pain relief for 15 min
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Total 12 sessions of trigger point dry needling at lumbar muscles with Hot pack,with 3 sessions per week Receives: Procedure: Dry needling; Procedure: Heat therapy |
| manual pressure release | Active comparator | Hot pack for 15 min then manual pressure release Receives: Procedure: Manual pressure release; Procedure: Heat therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
visual analogue scale
Measured: 4 weeks
functional disability
functional disability will be measured through oswestry disability index
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Oct 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Feb 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 PainStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- randomized control trial which will consist of two groups, control and experimental
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680493
- Sponsor's protocol ID
- FUI/CTR/2022/20
- Status last verified
- Dec 2022
- First submitted
- 26 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dry Needling and Manual Pressure Release for Managing Low Back Pain
- ClinicalTrials.gov ID
- NCT05680493
- Acronym / sponsor ID
- FUI/CTR/2022/20
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 11 Jan 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 will compare the effect of dry needling and manual pressure in patients having low back pain in terms of pain and disability. There will be two groups ; experimental and control. Half of study group will receive dry needling session along with hot pack. Half of study group will receive manual pressure technique along with hot pack.
Detailed description
The study is Randomized Control Trail , which is being conducted in fauji foundation hospital and Foundation University College Of Rehabilitation (oct 2022-feb 2023) . Sample size of 50 individual was calculated using epitool with 95% confidence interval (CI), and power 80%. sample will be collected through pilot study .
both groups will recieve conventional physiotherapy protocol (hot pack) Assessment will be done on baseline, and 4th week .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized control trial which will consist of two groups, control and experimental
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Procedure: Dry needling, Procedure: Heat therapyTotal 12 sessions of trigger point dry needling at lumbar muscles with Hot pack,with 3 sessions per week |
| manual pressure release | Active comparator | Procedure: Manual pressure release, Procedure: Heat therapyHot pack for 15 min then manual pressure release |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 30-60
- pateint with subacute and chronic low back pain at least last 6 months.
- pateint with active MTrps.
Key exclusion criteria (7 listed)
- patient with fibromyalgia
- pregnant females
- patient with chronic diseases (osteoporosis, lungs disease and diabetes)
- patient with musculoskeletal injuries
- patient that are using any medication to relief pain like analgesic or muscle relaxants
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 |
|---|---|---|
| Manual pressure releaselengthens the muscle up to the increasing resistance, then gradually applies gentle pressure on MTrp until fingers feels a definite increase in tissue resistance (first barrier). Pressure would maintain until clinician sense relief of tension | Procedure or surgery | manual pressure release |
| Dry needlingA filiform needle is inserted at 45 degree in to trigger point and then twirl the needle up and down to release trigger point | Procedure or surgery | Dry needling |
| Heat therapyHydro collator pack will be placed on affected area for relaxation and pain relief for 15 min | Procedure or surgery | Dry needling, manual pressure release |
Primary outcome
pain intensity
Time frame: 4 weeks
visual analogue scale
functional disability
Time frame: 4 weeks
functional disability will be measured through oswestry disability index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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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 Manual pressure release, Dry needling and Heat therapy in people with Low Back Pain, run by Foundation University Islamabad 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 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: status not confirmed, as of the sponsor's last update on 11 Jan 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?
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: 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 11 Jan 2023.