Chronic PainNCT04872335
Comparative Effects of Gong's Mobilization With Gradually Graded Exercise Therapy
A study testing Gong's Mobilization and Gradually Graded Exercise Therapy in people with Chronic Pain and Neck Pain, run by Riphah International University at 2 sites in Pakistan.
Trial summary
This project was a Randomized clinical trial conducted to find out the Comparative Effects of Gong's Mobilization with Gradually Graded Exercise Therapy for Chronic Neck Pain among the users of Electronic Gadgets so that we can have best treatment option for patients. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Chronic Pain, Neck Pain, Shoulder Syndrome
- What is being tested?
- Gong's Mobilization and Gradually Graded Exercise Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Oct 2020to 30 Jun 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- • Cervical stenosis
- History of traumatic Injury
- Previous surgery related to cervical spine
- Hypermobility
- Cancer
- Inflammatory rheumatologic diseases
Show all 9Show fewer
- Severe psychological disorders
- Being pregnant and
- Intervention including exercise or physical therapy in the last 3 months.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Riphah International University
Lahore, Punjab Province, 54000
Riphah IU
Lahore, 54000
About this study
Official title: Comparative Effects of Gong's Mobilization With Gradually Graded Exercise Therapy for Chronic Neck Pain Among the Electronic Gadgets Users.
This project was a Randomized clinical trial conducted to find out the Comparative Effects of Gong's Mobilization with Gradually Graded Exercise Therapy for Chronic Neck Pain among the users of Electronic Gadgets so that we can have best treatment option for patients.
Read the detailed description
The study design was a Randomized Clinical Trial. For the study data was collected from sports and spine professionals. Sample size was calculated with the help of Epitool calculator. The study will be completed in 6 months duration. Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS) for pain intensity and Universal Goniometers for measuring (ROMs) and Forward head posture (FHP) were assessed before and 4 weeks after the treatment through the craniovertebral angle (CVA) measured from a digitized, lateral-view photograph of each subject. All the subjects were selected using Non Probability convenient sampling technique. The Subjects were randomly assigned to one of the following two groups: Gong's Mobilization (Group 1) or Gradually Graded Exercise Therapy (Group 2).This study was conducted in accordance with the rules of the Declaration of Helsinki. Written Informed consent were taken from all the subjects before participating in this trial. SPSS 25 was used for data entry and analysis.
- Conditions
- Chronic Pain, Neck Pain, Shoulder Syndrome
- Being tested
- Gong's Mobilization, Gradually Graded Exercise Therapy
- Keywords
- Gong's Mobilization, Gradually graded exercise therapy
- Medical subject headings
- Chronic Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gong's MobilizationOther
Group A received Gong's mobilization and common treatnent (TENs,Hot pack and cervical stretches). Gong's mobilization which is concurrent application of Apophyseal joint gliding and end range passive physiological movements while the subject's cervical postures are passively Neutral in order to induce Normal Cervical Extension. The Subjects in Group A were treated three times in a week for 4 weeks.
Gradually Graded Exercise TherapyOther
The Subjects in Group B were received Exercise Therapy and common treatment (TENs, Hot pack and cervical stretches) three times in a week continue for 4 weeks . Each exercise session will take 30 min. It will be consisted of 5 min warm-up exercises, 20 min stabilization exercises, 5 min cool-down, and stretching exercises including neck and shoulder girdle muscles.
The aim of Exercise program was to create a neutral spine and activate deep muscles of the cervical spine. The patients were educated to maintain neutral spine during the exercises and throughout the day as much as possible.
Scapulothoracic stabilization exercises were included_ specific exercises for the muscles affecting scapular orientation related to neck pain. The subjects were educated to maintain the positions and contractions during the exercises including scapular retraction, eccentric scapular retraction, and combined scapular retraction with shoulder lateral rotation, forward punch, and dynamic hug.
| Study group | Role | What they receive |
|---|---|---|
| Gong's Mobilization | Experimental | Subjects received gong's mobilization three times in a week for 4 weeks. Receives: Other: Gong's Mobilization |
| Gradually Graded Exercise Therapy | Experimental | Subjects received gradually graded exercise therapy three times in a week for 4 weeks. Receives: Other: Gradually Graded Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity by 'Numeric Pain Rating Scale'
Change in pain from baseline was measured at 12th session. The Numerical Pain Rating Scale (NPRS) is an 11 point pain scale that is completed by subject himself, under the supervision of researcher.
Measured: Baseline (pre treatment readings), Immediate after treatment and post treatment readings( at 4th week)
Change in Neck disability Index 'NDI' score
Change in Neck disability Index score 'NDI' from baseline was measured at 12th session. This questionnaire or tool has been designed to give us information as to how neck pain of the subject has affected his/her ability to manage in everyday life.
Measured: Baseline (pre treatment readings), Immediate after treatment and post treatment readings( at 4th week)
Secondary outcomes (2)
Change in Cervical Range of Motion (ROM) measured by Universal Goniometer.
Change in Cervical Range of motion (ROM) from baseline was measured at 12th session.
Measured: Baseline (pre treatment readings), Immediate after treatment and post treatment readings( at 4th week)
Change in Craniovertebral angle CVA measured from a digitized, lateral-view photograph of each subject.
Change in Craniovertebral angle (CVA) from baseline was measured at 12th session. Craniovertebral angle (CVA) is a factor that significantly influences pain in those individuals with a forward head posture (FHP). Craniovertebral angle (CVA) (the angle between the horizontal line passing through C7 and a line extending from the tragus of the ear to C7).
Measured: Baseline (pre treatment readings), Immediate after treatment and post treatment readings( at 4th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start15 Oct 2020
- Primary completion30 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabiya Noor, Riphah International University
- Investigators
- Rabiya Noor, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872335
- Sponsor's protocol ID
- REC/Lhr/20/0104
- Status last verified
- Jul 2021
- First submitted
- 26 Mar 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Celenay ST, Kaya DO, Akbayrak T. Cervical and scapulothoracic stabilization exercises with and without connective tissue massage for chronic mechanical neck pain: A prospective, randomised controlled trial. Man Ther. 2016 Feb;21:144-50. doi: 10.1016/j.math.2015.07.003. Epub 2015 Jul 15.
PubMed 26211422Gong W. The effects of cervical joint manipulation, based on passive motion analysis, on cervical lordosis, forward head posture, and cervical ROM in university students with abnormal posture of the cervical spine. J Phys Ther Sci. 2015 May;27(5):1609-11. doi: 10.1589/jpts.27.1609. Epub 2015 May 26.
PubMed 26157273McLean SM, Klaber Moffett JA, Sharp DM, Gardiner E. A randomised controlled trial comparing graded exercise treatment and usual physiotherapy for patients with non-specific neck pain (the GET UP neck pain trial). Man Ther. 2013 Jun;18(3):199-205. doi: 10.1016/j.math.2012.09.005. Epub 2012 Oct 22.
PubMed 23085116Kim DH, Kim CJ, Son SM. Neck Pain in Adults with Forward Head Posture: Effects of Craniovertebral Angle and Cervical Range of Motion. Osong Public Health Res Perspect. 2018 Dec;9(6):309-313. doi: 10.24171/j.phrp.2018.9.6.04.
PubMed 30584494
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Gong's Mobilization With Gradually Graded Exercise Therapy for Chronic Neck Pain Among the Electronic Gadgets Users.
- ClinicalTrials.gov ID
- NCT04872335
- Acronym / sponsor ID
- REC/Lhr/20/0104
- Conditions
- Chronic Pain, Neck Pain, Shoulder Syndrome
- Keywords
- Gong's Mobilization, Gradually graded exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 4 May 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.
This project was a Randomized clinical trial conducted to find out the Comparative Effects of Gong's Mobilization with Gradually Graded Exercise Therapy for Chronic Neck Pain among the users of Electronic Gadgets so that we can have best treatment option for patients.
Detailed description
The study design was a Randomized Clinical Trial. For the study data was collected from sports and spine professionals. Sample size was calculated with the help of Epitool calculator. The study will be completed in 6 months duration. Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS) for pain intensity and Universal Goniometers for measuring (ROMs) and Forward head posture (FHP) were assessed before and 4 weeks after the treatment through the craniovertebral angle (CVA) measured from a digitized, lateral-view photograph of each subject. All the subjects were selected using Non Probability convenient sampling technique. The Subjects were randomly assigned to one of the following two groups: Gong's Mobilization (Group 1) or Gradually Graded Exercise Therapy (Group 2).This study was conducted in accordance with the rules of the Declaration of Helsinki. Written Informed consent were taken from all the subjects before participating in this trial. SPSS 25 was used for data entry and analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gong's Mobilization | Experimental | Other: Gong's MobilizationSubjects received gong's mobilization three times in a week for 4 weeks. |
| Gradually Graded Exercise Therapy | Experimental | Other: Gradually Graded Exercise TherapySubjects received gradually graded exercise therapy three times in a week for 4 weeks. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- • Cervical stenosis
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 |
|---|---|---|
| Gong's MobilizationGroup A received Gong's mobilization and common treatnent (TENs,Hot pack and cervical stretches). Gong's mobilization which is concurrent application of Apophyseal joint gliding and end range passive physiological movements while the subject's cervical postures are passively Neutral in order to induce Normal Cervical Extension. The Subjects in Group A were treated three times in a week for 4 weeks. | Other | Gong's Mobilization |
| Gradually Graded Exercise TherapyThe Subjects in Group B were received Exercise Therapy and common treatment (TENs, Hot pack and cervical stretches) three times in a week continue for 4 weeks . Each exercise session will take 30 min. It will be consisted of 5 min warm-up exercises, 20 min stabilization exercises, 5 min cool-down, and stretching exercises including neck and shoulder girdle muscles. The aim of Exercise program was to create a neutral spine and activate deep muscles of the cervical spine. The patients were educated to maintain neutral spine during the exercises and throughout the day as much as possible. Scapulothoracic stabilization exercises were included_ specific exercises for the muscles affecting scapular orientation related to neck pain. The subjects were educated to maintain the positions and contractions during the exercises including scapular retraction, eccentric scapular retraction, and combined scapular retraction with shoulder lateral rotation, forward punch, and dynamic hug. | Other | Gradually Graded Exercise Therapy |
Primary outcome
Change in Pain Intensity by 'Numeric Pain Rating Scale'
Time frame: Baseline (pre treatment readings), Immediate after treatment and post treatment readings( at 4th week)
Change in pain from baseline was measured at 12th session. The Numerical Pain Rating Scale (NPRS) is an 11 point pain scale that is completed by subject himself, under the supervision of researcher.
Change in Neck disability Index 'NDI' score
Time frame: Baseline (pre treatment readings), Immediate after treatment and post treatment readings( at 4th week)
Change in Neck disability Index score 'NDI' from baseline was measured at 12th session. This questionnaire or tool has been designed to give us information as to how neck pain of the subject has affected his/her ability to manage in everyday life.
2 secondary outcomes
Change in Cervical Range of Motion (ROM) measured by Universal Goniometer.
Time frame: Baseline (pre treatment readings), Immediate after treatment and post treatment readings( at 4th week)
Change in Craniovertebral angle CVA measured from a digitized, lateral-view photograph of each subject.
Time frame: Baseline (pre treatment readings), Immediate after treatment and post treatment readings( at 4th week)
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 14 Jul 2021.
- Background: PubMed 26211422Celenay ST, Kaya DO, Akbayrak T. Cervical and scapulothoracic stabilization exercises with and without connective tissue massage for chronic mechanical neck pain: A prospective, randomised controlled trial. Man Ther. 2016 Feb;21:144-50. doi: 10.1016/j.math.2015.07.003. Epub 2015 Jul 15.
- Background: PubMed 26157273Gong W. The effects of cervical joint manipulation, based on passive motion analysis, on cervical lordosis, forward head posture, and cervical ROM in university students with abnormal posture of the cervical spine. J Phys Ther Sci. 2015 May;27(5):1609-11. doi: 10.1589/jpts.27.1609. Epub 2015 May 26.
- Background: PubMed 23085116McLean SM, Klaber Moffett JA, Sharp DM, Gardiner E. A randomised controlled trial comparing graded exercise treatment and usual physiotherapy for patients with non-specific neck pain (the GET UP neck pain trial). Man Ther. 2013 Jun;18(3):199-205. doi: 10.1016/j.math.2012.09.005. Epub 2012 Oct 22.
- Background: PubMed 30584494Kim DH, Kim CJ, Son SM. Neck Pain in Adults with Forward Head Posture: Effects of Craniovertebral Angle and Cervical Range of Motion. Osong Public Health Res Perspect. 2018 Dec;9(6):309-313. doi: 10.24171/j.phrp.2018.9.6.04.
- 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.
Rabiya Noor, PhD principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gong's Mobilization and Gradually Graded Exercise Therapy in people with Chronic Pain and Neck Pain, run by Riphah International University at 2 sites 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 0 inclusion and 9 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 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 in Pain Intensity by 'Numeric Pain Rating Scale' (time frame: Baseline (pre treatment readings), Immediate after treatment and post treatment readings( at 4th week)). 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?
On the ClinicalTrials.gov record for NCT04872335, which also lists 4 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 14 Jul 2021.