Mechanical Neck PainNCT05618964

Effects Of Deep Neck Flexor And Extensor Exercises

A study testing Deep Neck Flexors & Extensors exercises in people with Mechanical Neck Pain, run by Riphah International University 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 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Mechanical Neck Pain
What is being tested?: Deep Neck Flexors & Extensors exercises
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 sitePakistan
Study dates: 18 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 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males and Females
18 and 40 years of age
Forward Head Posture
Manual Muscle testing (MMT) grade less than 6
Deep Flexor strength measured by pressure biofeedback unit (20 mmHg), patients who cannot hold craniocervical flexion (indicating yes) for 10 seconds

Who cannot join

Cervical radiculopathy
History of whiplash injury
History of cervical and thoracic spine surgery
Neck pain associated with vertigo
History of spinal osteoporosis
Vertebral Fractures
Tumors
Diagnosed psychological disorders

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Riphah Rehabilitation Clinic
Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Effects Of Deep Neck Flexor And Extensor Exercises On Pain, Range Of Motion And Muscle Strength In Mechanical Neck Pain

Deep cervical flexor and extensor muscles show decreased strength in patients with Mechanical neck pain. Exercises involving deep cervical muscles has improved coordination and motor control. This study aim to determine the effects of deep flexor muscle exercises along with deep extensor muscle exercises on pain, range of motion and muscle strength in mechanical neck pain.

Read the detailed description

This study will be a randomized controlled trial and will be conducted in Riphah Rehabilitation Clinic Lahore and Physiotherapy outpatient department of WAPDA Teaching Hospital Lahore. Non-probability consecutive sampling will be used to collect the data. Sample size of 36 subjects with age group between 18-40 years will be taken. Data will be collected from the patients having present complaint of Mechanical Neck pain. Outcome measures will be taken using Numeric pain rating scale (NPRS) for pain, Manual Muscle Testing (MMT) for muscle strength and Universal Goniometer (GU) for Range of motion. An informed consent will be taken. Subjects will be selected on the basis of inclusion and exclusion criteria and will be equally divided into two groups by random number generator table. Both the Groups will receive Hot Pack, superficial neck muscles stretching and Neck isometrics, while Group A will receive deep neck flexor and extensor exercises, and Group B will receive conventional treatment. Outcome measures will be measured at baseline and after 4 weeks. Data analysis will be done by SPSS version 25.

Conditions: Mechanical Neck Pain
Being tested: Deep Neck Flexors & Extensors exercises
Keywords: Neck muscles, Neck Pain, Muscle strength, Range of Motion
Medical subject headings: Neck Pain

What participants receive

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

Deep Neck Flexors & Extensors exercisesOther
Deep neck flexor exercises (2 set of 10 repetitions) that includes:
Contraction of deep neck flexor muscle in supine Craniocervical flexion in supine
Deep Neck Extensor exercises (2 set of 10 repetitions) that includes:
Contraction of deep neck extensors in quadruped position Segmented extension movement with the head bent down onto their chest in a horizontal direction,

Study groups in NCT05618964
Study group	Role	What they receive
Group A: Deep Neck Flexors & Extensors exercises	Experimental	Group A Patients will receive: Deep neck flexor exercises (2 set of 10 repetitions) that includes: * Contraction of deep neck flexor muscle in supine * Craniocervical flexion in supine Deep Neck Extensor exercises (2 set of 10 repetitions) that includes: * Contraction of deep neck extensors in quadruped position * Segmented extension movement with the head bent down onto their chest in a horizontal direction, Receives: Other: Deep Neck Flexors & Extensors exercises
Group B: Standardized Physical Therapy	No intervention	Standardized Physiotherapy treatment will be: * Hot pack for 10 minutes, * SNAG manual therapy at Cervical spine 6 repetitions for 60 seconds. * Superficial neck muscles (upper trapezius, Levator scapulae, Pect.Major) stretching for 3 times with 30 seconds and * Neck isometrics 10 times with 6 seconds hold. Both groups will come thrice per week for a total of 4 weeks. Pre and post treatment values of both groups will be analyzed

What is being measured

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

Numerical Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults, including those with chronic pain.
The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain.
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
The NPRS takes <1 minute to complete The NPRS is a valid and reliable scale to measure pain intensity;
- High test-retest reliability has been (r = 0.96 and 0.95, respectively)
- For construct validity, the NPRS was shown to be highly correlated: correlations range from 0.86 to 0.95
Measured: follow up on 4th week
Manual Muscle Testing (MMT)
Muscle strength will be assessed by Manual muscle testing. Which is scored using a 0-5 points Medical Research Council muscle strength scale. MMT is the most commonly used method for documenting impairments in muscle strength in both spine and periphery with a kappa value 0.88.
Measured: followup on 4th week
Universal Goniometer (UG)
A goniometer is an instrument that measures the available range of motion at a joint. To measure the range of motion physical therapists most commonly use a goniometer. It is necessary that a single notation system is used in goniometry. The neutral zero method (0 to 180- degree system) is the most widely used method. The same goniometer should always be used to reduce the chances of instrumental error. The range of motion of neck including flexion and extension will be measured by using universal goniometer that has an inter-rater reliability (ICC2, 2 = 0.79 to 0.92) for cervicle region.
Measured: follow up on 4th week
Pressure Biofeedback unit
Pressure biofeedback unit if placed under the suboccipital region and the pressure cuff is inflated to a pressure of 20 mmHg in order to fill the space of the cervical lordosis and the subject asked to perform a gentle head-nodding action of craniocervical flexion (indicating yes). Maximum pressure increase above the baseline upto 10 mmHg achieved and held for 10 seconds is defined as strength of deep cervical flexors.
Measured: follow up on 4th week

Timeline

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

18 Oct 20221 Feb 2023

First posted16 Nov 2022
Study start18 Oct 2022
Primary completion18 Jan 2023
Study completion1 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Mechanical Neck PainStudies of the same condition, open and under way.
More trials run by Riphah International 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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05618964
Sponsor's protocol ID: REC/RCR & AHS/22/0154 Zahra
Status last verified: Feb 2023
First submitted: 8 Nov 2022
Last updated: 21 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.
PubMed 34980079
Fandim JV, Nitzsche R, Michaleff ZA, Pena Costa LO, Saragiotto B. The contemporary management of neck pain in adults. Pain Manag. 2021 Jan;11(1):75-87. doi: 10.2217/pmt-2020-0046. Epub 2020 Nov 25.
PubMed 33234017
Gonzalez Rueda V, Lopez de Celis C, Barra Lopez ME, Carrasco Uribarren A, Castillo Tomas S, Hidalgo Garcia C. Effectiveness of a specific manual approach to the suboccipital region in patients with chronic mechanical neck pain and rotation deficit in the upper cervical spine: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Sep 5;18(1):384. doi: 10.1186/s12891-017-1744-5.
PubMed 28870191
Masaracchio M, Kirker K, States R, Hanney WJ, Liu X, Kolber M. Thoracic spine manipulation for the management of mechanical neck pain: A systematic review and meta-analysis. PLoS One. 2019 Feb 13;14(2):e0211877. doi: 10.1371/journal.pone.0211877. eCollection 2019.
PubMed 30759118
Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.
PubMed 34900443
Suvarnnato T, Puntumetakul R, Uthaikhup S, Boucaut R. Effect of specific deep cervical muscle exercises on functional disability, pain intensity, craniovertebral angle, and neck-muscle strength in chronic mechanical neck pain: a randomized controlled trial. J Pain Res. 2019 Mar 7;12:915-925. doi: 10.2147/JPR.S190125. eCollection 2019.
PubMed 30881101
Blomgren J, Strandell E, Jull G, Vikman I, Roijezon U. Effects of deep cervical flexor training on impaired physiological functions associated with chronic neck pain: a systematic review. BMC Musculoskelet Disord. 2018 Nov 28;19(1):415. doi: 10.1186/s12891-018-2324-z.
PubMed 30486819
Alghadir AH, Iqbal ZA. Effect of Deep Cervical Flexor Muscle Training Using Pressure Biofeedback on Pain and Forward Head Posture in School Teachers with Neck Pain: An Observational Study. Biomed Res Int. 2021 May 22;2021:5588580. doi: 10.1155/2021/5588580. eCollection 2021.
PubMed 34095302
Gimenez-Costa M, Schomacher J, Murillo C, Blanco-Hernandez T, Falla D, Lluch E. Specific versus non-specific exercises for the neck extensor muscles in women with chronic idiopathic neck pain: A randomized controlled trial. Musculoskelet Sci Pract. 2022 Aug;60:102561. doi: 10.1016/j.msksp.2022.102561. Epub 2022 Apr 6.
PubMed 35421696
Iqbal ZA, Alghadir AH, Anwer S. Efficacy of Deep Cervical Flexor Muscle Training on Neck Pain, Functional Disability, and Muscle Endurance in School Teachers: A Clinical Trial. Biomed Res Int. 2021 Jan 13;2021:7190808. doi: 10.1155/2021/7190808. eCollection 2021.
PubMed 33521131
Sikka I, Chawla C, Seth S, Alghadir AH, Khan M. Effects of Deep Cervical Flexor Training on Forward Head Posture, Neck Pain, and Functional Status in Adolescents Using Computer Regularly. Biomed Res Int. 2020 Oct 5;2020:8327565. doi: 10.1155/2020/8327565. eCollection 2020.
PubMed 33083487

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

Not yet recruiting
Effects of Mobilization With and Without Suboccipital Muscle Release on Pain, Range of Motion, and Disability in Mechanical Neck Pain
Mechanical Neck Pain
RecruitingObservational study
The Association Between Smartphone Overuse and Mechanical Neck Pain Among Galala University Students
Mechanical Neck Pain, Forward Head Posture (FHP)
Not yet recruitingObservational study
Relationship of Forward Head Posture With Burnout and Quality of Life
Forward Head Posture
Not yet recruiting
Comparison of Suboccipital Release and Muscle Energy Technique in Subjects With Mechanical Neck Pain and Forward Head Posture
Myofascial Trigger Points, Neck Pain
Recruiting
Biofeedback Exercises Versus Mulligan Concept on Pain, Mobility, and Posture in Females With Mechanical Neck Pain
Neck Pain, Cervical Spine Dysfunction

All Mechanical Neck Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects Of Deep Neck Flexor And Extensor Exercises On Pain, Range Of Motion And Muscle Strength In Mechanical Neck Pain
ClinicalTrials.gov ID: NCT05618964
Acronym / sponsor ID: REC/RCR & AHS/22/0154 Zahra
Conditions: Mechanical Neck Pain
Keywords: Neck muscles, Neck Pain, Muscle strength, Range of Motion
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Riphah International UniversityUniversity, hospital or other
Study start: 18 Oct 2022 (actual)
Primary completion: 18 Jan 2023 (actual)
Study completion: 1 Feb 2023 (actual)
First posted: 16 Nov 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group A: Deep Neck Flexors & Extensors exercises	Experimental	Other: Deep Neck Flexors & Extensors exercisesGroup A Patients will receive: Deep neck flexor exercises (2 set of 10 repetitions) that includes: * Contraction of deep neck flexor muscle in supine * Craniocervical flexion in supine Deep Neck Extensor exercises (2 set of 10 repetitions) that includes: * Contraction of deep neck extensors in quadruped position * Segmented extension movement with the head bent down onto their chest in a horizontal direction,
Group B: Standardized Physical Therapy	No intervention	–Standardized Physiotherapy treatment will be: * Hot pack for 10 minutes, * SNAG manual therapy at Cervical spine 6 repetitions for 60 seconds. * Superficial neck muscles (upper trapezius, Levator scapulae, Pect.Major) stretching for 3 times with 30 seconds and * Neck isometrics 10 times with 6 seconds hold. Both groups will come thrice per week for a total of 4 weeks. Pre and post treatment values of both groups will be analyzed

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Males and Females
18 and 40 years of age
Forward Head Posture
Manual Muscle testing (MMT) grade less than 6
Deep Flexor strength measured by pressure biofeedback unit (20 mmHg), patients who cannot hold craniocervical flexion (indicating yes) for 10 seconds

Key exclusion criteria (8 listed)

Cervical radiculopathy
History of whiplash injury
History of cervical and thoracic spine surgery
Neck pain associated with vertigo
History of spinal osteoporosis

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
Deep Neck Flexors & Extensors exercisesDeep neck flexor exercises (2 set of 10 repetitions) that includes: Contraction of deep neck flexor muscle in supine Craniocervical flexion in supine Deep Neck Extensor exercises (2 set of 10 repetitions) that includes: Contraction of deep neck extensors in quadruped position Segmented extension movement with the head bent down onto their chest in a horizontal direction,	Other	Group A: Deep Neck Flexors & Extensors exercises

Primary outcome

Numerical Pain Rating Scale (NPRS)
Time frame: follow up on 4th week
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults, including those with chronic pain. The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS takes <1 minute to complete The NPRS is a valid and reliable scale to measure pain intensity; * High test-retest reliability has been (r = 0.96 and 0.95, respectively) * For construct validity, the NPRS was shown to be highly correlated: correlations range from 0.86 to 0.95
Manual Muscle Testing (MMT)
Time frame: followup on 4th week
Muscle strength will be assessed by Manual muscle testing. Which is scored using a 0-5 points Medical Research Council muscle strength scale. MMT is the most commonly used method for documenting impairments in muscle strength in both spine and periphery with a kappa value 0.88.
Universal Goniometer (UG)
Time frame: follow up on 4th week
A goniometer is an instrument that measures the available range of motion at a joint. To measure the range of motion physical therapists most commonly use a goniometer. It is necessary that a single notation system is used in goniometry. The neutral zero method (0 to 180- degree system) is the most widely used method. The same goniometer should always be used to reduce the chances of instrumental error. The range of motion of neck including flexion and extension will be measured by using universal goniometer that has an inter-rater reliability (ICC2, 2 = 0.79 to 0.92) for cervicle region.
Pressure Biofeedback unit
Time frame: follow up on 4th week
Pressure biofeedback unit if placed under the suboccipital region and the pressure cuff is inflated to a pressure of 20 mmHg in order to fill the space of the cervical lordosis and the subject asked to perform a gentle head-nodding action of craniocervical flexion (indicating yes). Maximum pressure increase above the baseline upto 10 mmHg achieved and held for 10 seconds is defined as strength of deep cervical flexors.

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 21 Feb 2023.
Background: PubMed 34980079Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.
Background: PubMed 33234017Fandim JV, Nitzsche R, Michaleff ZA, Pena Costa LO, Saragiotto B. The contemporary management of neck pain in adults. Pain Manag. 2021 Jan;11(1):75-87. doi: 10.2217/pmt-2020-0046. Epub 2020 Nov 25.
Background: PubMed 28870191Gonzalez Rueda V, Lopez de Celis C, Barra Lopez ME, Carrasco Uribarren A, Castillo Tomas S, Hidalgo Garcia C. Effectiveness of a specific manual approach to the suboccipital region in patients with chronic mechanical neck pain and rotation deficit in the upper cervical spine: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Sep 5;18(1):384. doi: 10.1186/s12891-017-1744-5.
Background: PubMed 30759118Masaracchio M, Kirker K, States R, Hanney WJ, Liu X, Kolber M. Thoracic spine manipulation for the management of mechanical neck pain: A systematic review and meta-analysis. PLoS One. 2019 Feb 13;14(2):e0211877. doi: 10.1371/journal.pone.0211877. eCollection 2019.
Background: PubMed 34900443Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.
Background: PubMed 30881101Suvarnnato T, Puntumetakul R, Uthaikhup S, Boucaut R. Effect of specific deep cervical muscle exercises on functional disability, pain intensity, craniovertebral angle, and neck-muscle strength in chronic mechanical neck pain: a randomized controlled trial. J Pain Res. 2019 Mar 7;12:915-925. doi: 10.2147/JPR.S190125. eCollection 2019.
Background: PubMed 30486819Blomgren J, Strandell E, Jull G, Vikman I, Roijezon U. Effects of deep cervical flexor training on impaired physiological functions associated with chronic neck pain: a systematic review. BMC Musculoskelet Disord. 2018 Nov 28;19(1):415. doi: 10.1186/s12891-018-2324-z.
Background: PubMed 34095302Alghadir AH, Iqbal ZA. Effect of Deep Cervical Flexor Muscle Training Using Pressure Biofeedback on Pain and Forward Head Posture in School Teachers with Neck Pain: An Observational Study. Biomed Res Int. 2021 May 22;2021:5588580. doi: 10.1155/2021/5588580. eCollection 2021.
Background: PubMed 35421696Gimenez-Costa M, Schomacher J, Murillo C, Blanco-Hernandez T, Falla D, Lluch E. Specific versus non-specific exercises for the neck extensor muscles in women with chronic idiopathic neck pain: A randomized controlled trial. Musculoskelet Sci Pract. 2022 Aug;60:102561. doi: 10.1016/j.msksp.2022.102561. Epub 2022 Apr 6.
Background: PubMed 33521131Iqbal ZA, Alghadir AH, Anwer S. Efficacy of Deep Cervical Flexor Muscle Training on Neck Pain, Functional Disability, and Muscle Endurance in School Teachers: A Clinical Trial. Biomed Res Int. 2021 Jan 13;2021:7190808. doi: 10.1155/2021/7190808. eCollection 2021.
Background: PubMed 33083487Sikka I, Chawla C, Seth S, Alghadir AH, Khan M. Effects of Deep Cervical Flexor Training on Forward Head Posture, Neck Pain, and Functional Status in Adolescents Using Computer Regularly. Biomed Res Int. 2020 Oct 5;2020:8327565. doi: 10.1155/2020/8327565. eCollection 2020.
Individual participant dataSharing planned: No

Related trials for Mechanical Neck Pain

Not yet recruiting
Effects of Mobilization With and Without Suboccipital Muscle Release on Pain, Range of Motion, and Disability in Mechanical Neck Pain
Mechanical Neck Pain
RecruitingObservational study
The Association Between Smartphone Overuse and Mechanical Neck Pain Among Galala University Students
Mechanical Neck Pain, Forward Head Posture (FHP)
Not yet recruitingObservational study
Relationship of Forward Head Posture With Burnout and Quality of Life
Forward Head Posture
Not yet recruiting
Comparison of Suboccipital Release and Muscle Energy Technique in Subjects With Mechanical Neck Pain and Forward Head Posture
Myofascial Trigger Points, Neck Pain
Recruiting
Biofeedback Exercises Versus Mulligan Concept on Pain, Mobility, and Posture in Females With Mechanical Neck Pain
Neck Pain, Cervical Spine Dysfunction

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.

Samrood Akram, Mphil principal investigator

Riphah International University,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 Deep Neck Flexors & Extensors exercises in people with Mechanical Neck Pain, run by Riphah International University 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 5 inclusion and 8 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 21 Feb 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?

Numerical Pain Rating Scale (NPRS) (time frame: follow up on 4th week). The study lists 4 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 NCT05618964, which also lists 11 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 21 Feb 2023.