Mechanical Neck PainNCT05044078

Effects of Autogenic and Reciprocal Inhibition Techniques With Conventional Therapy in Mechanical Neck Pain

A study testing Autogenic Inhibition MET and Reciprocal Inhibition MET in people with Mechanical Neck Pain, run by Dow University of Health Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 20 to 50 years
Conditions the study is for: Mechanical Neck Pain
What is being tested?: Autogenic Inhibition MET and Reciprocal Inhibition MET
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 sitePakistan
Study dates: 28 Aug 2021to 31 Dec 2021
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 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Moderate intensity (3.5-7.4cm) Pain on VAS
Limited or Painful Cervical ROM
Pain more than 4 weeks (sub-acute and chronic)
20-50 years Age

Who cannot join

Any Symptom and sign of Radiculopathy and Myelopathy
Any neurological disease like Multiple Sclerosis, Parkinson or Stroke
Taking any Pain medication
Trigger Point of Upper Trapezius
Any fracture, surgical procedure, or trauma of the cervical spine
Any red flag or signs of serious pathology like rheumatic or inflammatory diseases, malignancy, infection, or vascular disease such as Vertebro-Basilar Insufficiency.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Sindh Institue of Physical Medicine and Rehabilitation
Karachi, Sindh, 74200

Other trials in Pakistan

About this study

Official title: Effects of Autogenic and Reciprocal Inhibition Techniques With Conventional Therapy in Mechanical Neck Pain- A Randomized Control Trial

The objective of this randomized control trial is to determine the effectiveness of Autogenic and Reciprocal Inhibition techniques with conventional therapy in mechanical neck pain to improve Pain, Range of Motion, and Functional Disability in long term. This study is being conducted at the Physiotherapy department of Sindh Institute of Physical Medicine and Rehabilitation, Karachi (former institute of Dow University of Health Sciences) among 80 patients with mechanical neck pain on the basis of non-probability purposive sample technique with screening for study criteria through a consultant physician (blinded) . After taking informed consent all participants will be randomly allocated in two groups through second researcher who is not involved in screening, baseline assessment and providing intervention. Group 1 will receive Autogenic Inhibition muscle energy technique (MET) with conventional therapy and Group 2 will receive Reciprocal inhibition MET with conventional therapy. A total of 12 sessions will be provided. Outcomes will be assessed at baseline, after 1st session, and at last session.

Conditions: Mechanical Neck Pain
Being tested: Autogenic Inhibition MET, Reciprocal Inhibition MET
Keywords: Neck Pain, Manual Therapies, Therapy-Soft Tissue, Muscle Stretching exercises
Medical subject headings: Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autogenic Inhibition METOther
If a sub-maximal contraction of the muscle is followed by stretching of the same muscle it is known as Autogenic Inhibition MET.
Reciprocal Inhibition METOther
If a submaximal contraction of a muscle is followed by stretching of the opposite muscle then this is known as Reciprocal Inhibition MET.

Study groups in NCT05044078
Study group	Role	What they receive
Group 1 (Autogenic Inhibition)	Experimental	Autogenic Inhibition (5 reps, 10-sec hold, 5-sec rest in between each rep, 1 set, in all sessions) will be provided with the Conventional therapy including neck Isometric strengthening exercise (Neck Flexion, Extension, Both sides Rotation, and Neck Bending with each 5 rep, 10-sec hold, 1 set, in all sessions), Maitland Central posterio-anterior glide (Grade 1 and 2, 30 rep, 3 sets, in all sessions) and hot pack (10 minutes in all sessions on the back of the neck) Receives: Other: Autogenic Inhibition MET
Group 2 (Reciprocal Inhibition)	Active comparator	Reciprocal Inhibition (5 reps, 10-sec hold, 5-sec rest in between each rep, 1 set, in all sessions) will be provided with the with same Conventional therapy as in group 1 . Receives: Other: Reciprocal Inhibition MET

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in pain on the 10 centimetre Visual analogue scale (VAS-10cm) at first day.
The patient will asked to mark the pain Intensity on the line of 0-10cm that measures the level of pain. The 0 refers no pain and 10-cm refers excruciating pain as perceived as maximum.
Measured: Baseline and 1 day
Change from baseline in pain on the 10 centimetre Visual analogue scale (VAS-10cm) at 12 session.
The patient will asked to mark the pain Intensity on the line of 0-10cm that measures the level of pain. The 0 refers no pain and 10-cm refers excruciating pain as perceived as maximum
Measured: Baseline and 3 weeks
Change from baseline in disability on the Neck Disability Index (NDI) at first session.
This questionnaire has been designed to give information as to neck pain of patient has affected the ability to manage in everyday life. Patient will be asked to answer every section and mark in each section only the one box that most closely describes his or her problem. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score.The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. The 0 points or 0% means : no activity limitations, 50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. It is available in both English and Urdu. Minimum Detectable Change (90% confidence): 5 points or 10% points.
Measured: Baseline and 1 day
Change from baseline in disability on the Neck Disability Index (NDI) at 12 sessions.
This questionnaire has been designed to give information as to neck pain of patient has affected the ability to manage in everyday life. Patient will be asked to answer every section and mark in each section only the one box that most closely describes his or her problem. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score.The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. The 0 points or 0% means : no activity limitations, 50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. It is available in both English and Urdu. Minimum Detectable Change (90% confidence): 5 points or 10% points.
Measured: Baseline and 3 weeks
Change from baseline in Neck range of motion measured through Goniometer at first session.
It is an instrument that is used to measures the available Range of Motion around a joint in degrees. The investigator will appropriately place goniometer to measure the range of motions of neck (Flexion, extension, right and left lateral flexion and rotation). Lower the reading of goniometer suggests decreased in range of motion and vice versa.
Measured: Baseline and 1 day
Change from baseline in Neck range of motion measured through Goniometer at 12 session.
It is an instrument that is used to measures the available Range of Motion around a joint in degrees. The investigator will appropriately place goniometer to measure the range of motions of neck (Flexion, extension, right and left lateral flexion and rotation). Lower the reading of goniometer suggests decreased in range of motion and vice versa.
Measured: Baseline and 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 202131 Dec 2021

First posted14 Sep 2021
Study start28 Aug 2021
Primary completion31 Dec 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (32)Papers the sponsor has linked to this study.
Other trials for Mechanical Neck PainStudies 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
Model description: It is a randomized control trial. Total 80 patients will be recruited, 40 in each group that includes 10 patients as a dropout in both groups. There will be one interventional group and one active comparator group. Treatment will be allocated using a random number sheet generated by statistician. Participants are assigned to one of two groups in parallel for the duration of the study.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05044078
Sponsor's protocol ID: MSiddiqi
Status last verified: Feb 2022
First submitted: 4 Sep 2021
Last updated: 3 Feb 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hoy D, March L, Woolf A, Blyth F, Brooks P, Smith E, Vos T, Barendregt J, Blore J, Murray C, Burstein R, Buchbinder R. The global burden of neck pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1309-15. doi: 10.1136/annrheumdis-2013-204431. Epub 2014 Jan 30.
PubMed 24482302
Safiri S, Kolahi AA, Hoy D, Buchbinder R, Mansournia MA, Bettampadi D, Ashrafi-Asgarabad A, Almasi-Hashiani A, Smith E, Sepidarkish M, Cross M, Qorbani M, Moradi-Lakeh M, Woolf AD, March L, Collins G, Ferreira ML. Global, regional, and national burden of neck pain in the general population, 1990-2017: systematic analysis of the Global Burden of Disease Study 2017. BMJ. 2020 Mar 26;368:m791. doi: 10.1136/bmj.m791.
PubMed 32217608
Binder AI. Neck pain. BMJ Clin Evid. 2008 Aug 4;2008:1103.
PubMed 19445809
Evans G. Identifying and treating the causes of neck pain. Med Clin North Am. 2014 May;98(3):645-61. doi: 10.1016/j.mcna.2014.01.015. Epub 2014 Mar 22.
PubMed 24758966
Heintz MM, Hegedus EJ. Multimodal management of mechanical neck pain using a treatment based classification system. J Man Manip Ther. 2008;16(4):217-24. doi: 10.1179/106698108790818260.
PubMed 19771194
Karnath BM. Identifying the musculoskeletal causes of neck pain [Internet]. Rheumatologynethreefiverk.com. [cited 2021 Apr 2]. Available from: https://www.rheumatologynetwork.com/view/identifying-musculoskeletal-causes-neck-pain
Binder AI. Cervical spondylosis and neck pain. BMJ. 2007 Mar 10;334(7592):527-31. doi: 10.1136/bmj.39127.608299.80. No abstract available.
PubMed 17347239
Miller J, Gross A, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL. Manual therapy and exercise for neck pain: a systematic review. Man Ther. 2010 Aug;15(4):334-54.
PubMed 20593537
Gross A, Kay TM, Paquin JP, Blanchette S, Lalonde P, Christie T, Dupont G, Graham N, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Hoving JL, Bronfort G, Santaguida PL; Cervical Overview Group. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2015 Jan 28;1(1):CD004250. doi: 10.1002/14651858.CD004250.pub5.
PubMed 25629215
What can you do about non-specific neck pain? Institute for Quality and Efficiency in Health Care (IQWiG); 2019.
Phadke A, Bedekar N, Shyam A, Sancheti P. Effect of muscle energy technique and static stretching on pain and functional disability in patients with mechanical neck pain: A randomized controlled trial. Hong Kong Physiother J. 2016 Apr 14;35:5-11. doi: 10.1016/j.hkpj.2015.12.002. eCollection 2016 Dec.
PubMed 30931028
Waxenbaum JA, Sina RE, Lu M. Physiology, Muscle Energy. 2026 Feb 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559029/
PubMed 32644455
Elsevier. Muscle Energy Techniques E-Book [Internet]. Elsevier.com. [cited 2021 Apr 2]. Available from: https://www.elsevier.com/books/muscle-energy-techniques-with-dvdrom/chaitow/978-0-7020-3243-1.
Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
PubMed 28666405
Osama M, Shakil Ur Rehman S. Effects of static stretching as compared to autogenic inhibition and reciprocal inhibition muscle energy techniques in the management of mechanical neck pain: a randomized controlled trial. J Pak Med Assoc. 2020 May;70(5):786-790. doi: 10.5455/JPMA.9596.
PubMed 32400728

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mechanical Neck Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Autogenic and Reciprocal Inhibition Techniques With Conventional Therapy in Mechanical Neck Pain- A Randomized Control Trial
ClinicalTrials.gov ID: NCT05044078
Acronym / sponsor ID: MSiddiqi
Conditions: Mechanical Neck Pain
Keywords: Neck Pain, Manual Therapies, Therapy-Soft Tissue, Muscle Stretching exercises
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Dow University of Health SciencesUniversity, hospital or other
Study start: 28 Aug 2021 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 14 Sep 2021 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: It is a randomized control trial. Total 80 patients will be recruited, 40 in each group that includes 10 patients as a dropout in both groups. There will be one interventional group and one active comparator group. Treatment will be allocated using a random number sheet generated by statistician. Participants are assigned to one of two groups in parallel for the duration of the study.

Arm	Type	Receives
Group 1 (Autogenic Inhibition)	Experimental	Other: Autogenic Inhibition METAutogenic Inhibition (5 reps, 10-sec hold, 5-sec rest in between each rep, 1 set, in all sessions) will be provided with the Conventional therapy including neck Isometric strengthening exercise (Neck Flexion, Extension, Both sides Rotation, and Neck Bending with each 5 rep, 10-sec hold, 1 set, in all sessions), Maitland Central posterio-anterior glide (Grade 1 and 2, 30 rep, 3 sets, in all sessions) and hot pack (10 minutes in all sessions on the back of the neck)
Group 2 (Reciprocal Inhibition)	Active comparator	Other: Reciprocal Inhibition METReciprocal Inhibition (5 reps, 10-sec hold, 5-sec rest in between each rep, 1 set, in all sessions) will be provided with the with same Conventional therapy as in group 1 .

Who may qualify

Ages: 20 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Moderate intensity (3.5-7.4cm) Pain on VAS
Limited or Painful Cervical ROM
Pain more than 4 weeks (sub-acute and chronic)
20-50 years Age

Key exclusion criteria (6 listed)

Any Symptom and sign of Radiculopathy and Myelopathy
Any neurological disease like Multiple Sclerosis, Parkinson or Stroke
Taking any Pain medication
Trigger Point of Upper Trapezius
Any fracture, surgical procedure, or trauma of the cervical spine

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
Autogenic Inhibition METIf a sub-maximal contraction of the muscle is followed by stretching of the same muscle it is known as Autogenic Inhibition MET.	Other	Group 1 (Autogenic Inhibition)
Reciprocal Inhibition METIf a submaximal contraction of a muscle is followed by stretching of the opposite muscle then this is known as Reciprocal Inhibition MET.	Other	Group 2 (Reciprocal Inhibition)

Primary outcome

Change from baseline in pain on the 10 centimetre Visual analogue scale (VAS-10cm) at first day.
Time frame: Baseline and 1 day
The patient will asked to mark the pain Intensity on the line of 0-10cm that measures the level of pain. The 0 refers no pain and 10-cm refers excruciating pain as perceived as maximum.
Change from baseline in pain on the 10 centimetre Visual analogue scale (VAS-10cm) at 12 session.
Time frame: Baseline and 3 weeks
The patient will asked to mark the pain Intensity on the line of 0-10cm that measures the level of pain. The 0 refers no pain and 10-cm refers excruciating pain as perceived as maximum
Change from baseline in disability on the Neck Disability Index (NDI) at first session.
Time frame: Baseline and 1 day
This questionnaire has been designed to give information as to neck pain of patient has affected the ability to manage in everyday life. Patient will be asked to answer every section and mark in each section only the one box that most closely describes his or her problem. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score.The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. The 0 points or 0% means : no activity limitations, 50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. It is available in both English and Urdu. Minimum Detectable Change (90% confidence): 5 points or 10% points.
Change from baseline in disability on the Neck Disability Index (NDI) at 12 sessions.
Time frame: Baseline and 3 weeks
This questionnaire has been designed to give information as to neck pain of patient has affected the ability to manage in everyday life. Patient will be asked to answer every section and mark in each section only the one box that most closely describes his or her problem. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score.The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. The 0 points or 0% means : no activity limitations, 50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. It is available in both English and Urdu. Minimum Detectable Change (90% confidence): 5 points or 10% points.
Change from baseline in Neck range of motion measured through Goniometer at first session.
Time frame: Baseline and 1 day
It is an instrument that is used to measures the available Range of Motion around a joint in degrees. The investigator will appropriately place goniometer to measure the range of motions of neck (Flexion, extension, right and left lateral flexion and rotation). Lower the reading of goniometer suggests decreased in range of motion and vice versa.
Change from baseline in Neck range of motion measured through Goniometer at 12 session.
Time frame: Baseline and 3 weeks
It is an instrument that is used to measures the available Range of Motion around a joint in degrees. The investigator will appropriately place goniometer to measure the range of motions of neck (Flexion, extension, right and left lateral flexion and rotation). Lower the reading of goniometer suggests decreased in range of motion and vice versa.

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 3 Feb 2022.
Background: PubMed 24482302Hoy D, March L, Woolf A, Blyth F, Brooks P, Smith E, Vos T, Barendregt J, Blore J, Murray C, Burstein R, Buchbinder R. The global burden of neck pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1309-15. doi: 10.1136/annrheumdis-2013-204431. Epub 2014 Jan 30.
Background: PubMed 32217608Safiri S, Kolahi AA, Hoy D, Buchbinder R, Mansournia MA, Bettampadi D, Ashrafi-Asgarabad A, Almasi-Hashiani A, Smith E, Sepidarkish M, Cross M, Qorbani M, Moradi-Lakeh M, Woolf AD, March L, Collins G, Ferreira ML. Global, regional, and national burden of neck pain in the general population, 1990-2017: systematic analysis of the Global Burden of Disease Study 2017. BMJ. 2020 Mar 26;368:m791. doi: 10.1136/bmj.m791.
Background: PubMed 19445809Binder AI. Neck pain. BMJ Clin Evid. 2008 Aug 4;2008:1103.
Background: PubMed 24758966Evans G. Identifying and treating the causes of neck pain. Med Clin North Am. 2014 May;98(3):645-61. doi: 10.1016/j.mcna.2014.01.015. Epub 2014 Mar 22.
Background: PubMed 19771194Heintz MM, Hegedus EJ. Multimodal management of mechanical neck pain using a treatment based classification system. J Man Manip Ther. 2008;16(4):217-24. doi: 10.1179/106698108790818260.
BackgroundKarnath BM. Identifying the musculoskeletal causes of neck pain [Internet]. Rheumatologynethreefiverk.com. [cited 2021 Apr 2]. Available from: https://www.rheumatologynetwork.com/view/identifying-musculoskeletal-causes-neck-pain
Background: PubMed 17347239Binder AI. Cervical spondylosis and neck pain. BMJ. 2007 Mar 10;334(7592):527-31. doi: 10.1136/bmj.39127.608299.80. No abstract available.
Background: PubMed 20593537Miller J, Gross A, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL. Manual therapy and exercise for neck pain: a systematic review. Man Ther. 2010 Aug;15(4):334-54.
Background: PubMed 25629215Gross A, Kay TM, Paquin JP, Blanchette S, Lalonde P, Christie T, Dupont G, Graham N, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Hoving JL, Bronfort G, Santaguida PL; Cervical Overview Group. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2015 Jan 28;1(1):CD004250. doi: 10.1002/14651858.CD004250.pub5.
BackgroundWhat can you do about non-specific neck pain? Institute for Quality and Efficiency in Health Care (IQWiG); 2019.
Background: PubMed 30931028Phadke A, Bedekar N, Shyam A, Sancheti P. Effect of muscle energy technique and static stretching on pain and functional disability in patients with mechanical neck pain: A randomized controlled trial. Hong Kong Physiother J. 2016 Apr 14;35:5-11. doi: 10.1016/j.hkpj.2015.12.002. eCollection 2016 Dec.
Background: PubMed 32644455Waxenbaum JA, Sina RE, Lu M. Physiology, Muscle Energy. 2026 Feb 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559029/
Individual participant dataSharing planned: No

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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.

Mahrukh Siddiqi, MSAPT principal investigator

Dow University of Health Sciences

Saeed Akhter, MSPT study director

Sindh Institute of Physical Medicine and Rehabilitation, Karachi, Pakistan

Aftab Ahmed Mirza Baig, MSAPT principal investigator

Sindh Institute of Physical Medicine and Rehabilitation, Karachi, Pakistan.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Autogenic Inhibition MET and Reciprocal Inhibition MET in people with Mechanical Neck 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 4 inclusion and 6 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 3 Feb 2022. 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?

Change from baseline in pain on the 10 centimetre Visual analogue scale (VAS-10cm) at first day. (time frame: Baseline and 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05044078, which also lists 32 linked publications.

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 3 Feb 2022.