Neck PainNCT06086782
Effects of Autogenic and Reciprocal Inhibition on Trapezitis
A study testing autogenic inhibition and reciprocal inhibition in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Aim of my study is to compare two techniques of METS i.e., autogenic and reciprocal inhibition techniques on pain, disability and Range of motion among smart phone user with trapezitis. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- autogenic inhibition and reciprocal inhibition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Oct 2023to Dec 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mobile phone users age between 20 -40 years old.
- Both gender male and female included.
- Neck pain (Numeric Pain Rating Scale >3)
- With limited Neck ROMs.
- NDI scoring 15-24points (30-48%) moderate disability
Who cannot join
- Neck pain with whiplash or headache, neurological disorder.
- History of previous head, neck, cervical spine or shoulder surgery.
- Infection or inflammatory arthritis in the cervical spine.
- Trigger point of Upper trapezius will be excluded.
- History of cervical radiculopathy.
- Diagnosed fibromyalgia and myopathy.
- History of cancer.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Nusrat Rashid Medical Complex
Lahore, Punjab Province, 16454
Haroon Rashid Rashid, MBBS, 03060063311, info@nusratrashidmedicalcomplex.com
Muhammad Awais Hassan, MS
About this study
Official title: Comparative Effects of Autogenic and Reciprocal Inhibition Techniques on Pain, Disability and Range of Motion Among Smart Phone User With Trapezitis
Aim of my study is to compare two techniques of METS i.e., autogenic and reciprocal inhibition techniques on pain, disability and Range of motion among smart phone user with trapezitis.
Read the detailed description
Study focuses trapezitis in smart phone users. There are many different causes of neck pain, but one common factor is upper trapezitis. This refers to pain and spasms in the neck caused by inflammation of the trapezius muscle. The aim of this study is to compare the effects of autogenic and reciprocal inhibition techniques on pain, range of motion and disability among smart phone user with trapezitis.
This study will be randomized clinical trial and 40 patients male and female with age 20 to 40 years having NPRS >3 according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability convenience sampling technique. Group A will receive autogenic inhibition technique with conventional physical therapy while Group B will receive reciprocal inhibition technique with conventional therapy. Outcome measures; Neck Disability Index, goniometry and Numeric Pain Rating Scale will measure neck function and neck pain intensity. Total 12 sessions, 3 sessions per week for 4 weeks were provided. Each session was 45 minutes long and measurements will be taken at the baseline and at the end of 4th week. Data will be analyzed by SPSS version 25
- Conditions
- Neck Pain
- Being tested
- autogenic inhibition, reciprocal inhibition
- Keywords
- trapezitis, Disability, neck pain
- 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 inhibitionOther
Group 1 will receive AI-MET with conventional treatment. AI include stretching of the affected muscle and performing isometric contraction with 50% of the total patient's effort in the same muscle that will being stretched and position hold for 10 seconds, with 5 seconds of rest after every repetition. This procedure will repeat 5 times.
reciprocal inhibitionOther
Group 2 receive RI-MET with conventional treatment. The RI also include stretching of the affected muscle but contrary to AI, isometric contraction of the antagonist muscles with the 50% of total patient's effort will follow. This position holds for 10 seconds, while agonist's muscle will still in the stretched position, with 5 seconds of rest after every repetition. This procedure will repeat 5 times too.
| Study group | Role | What they receive |
|---|---|---|
| autogenic inhibition | Experimental | isometric of muscles and stretching of the same side Receives: Other: autogenic inhibition |
| reciprocal inhibition | Experimental | isometric of muscles and stretching of the opposite side Receives: Other: reciprocal inhibition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometry
The art and science of measuring the joint ranges in each plane of the joint are called goniometry. The term 'goniometry' has its origin from two Greek words, gonia, which means angle, and metron, which means to measure. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. A universal goniometer has three parts. The fulcrum and the body are placed over the joint being measured. The stationary arm is the arm of the goniometer that aligns with the inactive part of the joint measured. It is structurally a part of the body and is not movable independently of the body. The moving arm is the arm of the goniometer, which aligns with the mobile part of the joint measured. Neck flexion, extension, side bending and rotation will be assessed through it
Measured: 4 weeks
Secondary outcomes (2)
NPRS (numeric pain rating scale)
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale. The common format is a horizontal bar or line. Although various iterations exist, the most commonly used is the 11-item NPRS. 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 is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain. Reliability of NPRS is (r=0.96 and 0.95) and validity is from 0.86 to 0.95
Measured: 4 weeks
NDI (neck disability index)
The Neck Disability Index (NDI) (modification of the Oswestry Low Back Pain Disability Index). This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. Scoring for each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. The maximum score is 50 (20). Reliability of NDI is 0.50 and 0.98
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 posted17 Oct 2023
- Study start10 Oct 2023
- Primary completion30 Nov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Humera Mubashar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086782
- Sponsor's protocol ID
- REC/RCR & AHS/23/0145
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Autogenic and Reciprocal Inhibition Techniques on Pain, Disability and Range of Motion Among Smart Phone User With Trapezitis
- ClinicalTrials.gov ID
- NCT06086782
- Acronym / sponsor ID
- REC/RCR & AHS/23/0145
- Conditions
- Neck Pain
- Keywords
- trapezitis, Disability, neck pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Oct 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.
Aim of my study is to compare two techniques of METS i.e., autogenic and reciprocal inhibition techniques on pain, disability and Range of motion among smart phone user with trapezitis.
Detailed description
Study focuses trapezitis in smart phone users. There are many different causes of neck pain, but one common factor is upper trapezitis. This refers to pain and spasms in the neck caused by inflammation of the trapezius muscle. The aim of this study is to compare the effects of autogenic and reciprocal inhibition techniques on pain, range of motion and disability among smart phone user with trapezitis.
This study will be randomized clinical trial and 40 patients male and female with age 20 to 40 years having NPRS >3 according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability convenience sampling technique. Group A will receive autogenic inhibition technique with conventional physical therapy while Group B will receive reciprocal inhibition technique with conventional therapy. Outcome measures; Neck Disability Index, goniometry and Numeric Pain Rating Scale will measure neck function and neck pain intensity. Total 12 sessions, 3 sessions per week for 4 weeks were provided. Each session was 45 minutes long and measurements will be taken at the baseline and at the end of 4th week. Data will be analyzed by SPSS version 25
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autogenic inhibition | Experimental | Other: autogenic inhibitionisometric of muscles and stretching of the same side |
| reciprocal inhibition | Experimental | Other: reciprocal inhibitionisometric of muscles and stretching of the opposite side |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Mobile phone users age between 20 -40 years old.
- Both gender male and female included.
- Neck pain (Numeric Pain Rating Scale >3)
- With limited Neck ROMs.
- NDI scoring 15-24points (30-48%) moderate disability
Key exclusion criteria (7 listed)
- Neck pain with whiplash or headache, neurological disorder.
- History of previous head, neck, cervical spine or shoulder surgery.
- Infection or inflammatory arthritis in the cervical spine.
- Trigger point of Upper trapezius will be excluded.
- History of cervical radiculopathy.
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 inhibitionGroup 1 will receive AI-MET with conventional treatment. AI include stretching of the affected muscle and performing isometric contraction with 50% of the total patient's effort in the same muscle that will being stretched and position hold for 10 seconds, with 5 seconds of rest after every repetition. This procedure will repeat 5 times. | Other | autogenic inhibition |
| reciprocal inhibitionGroup 2 receive RI-MET with conventional treatment. The RI also include stretching of the affected muscle but contrary to AI, isometric contraction of the antagonist muscles with the 50% of total patient's effort will follow. This position holds for 10 seconds, while agonist's muscle will still in the stretched position, with 5 seconds of rest after every repetition. This procedure will repeat 5 times too. | Other | reciprocal inhibition |
Primary outcome
Goniometry
Time frame: 4 weeks
The art and science of measuring the joint ranges in each plane of the joint are called goniometry. The term 'goniometry' has its origin from two Greek words, gonia, which means angle, and metron, which means to measure. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. A universal goniometer has three parts. The fulcrum and the body are placed over the joint being measured. The stationary arm is the arm of the goniometer that aligns with the inactive part of the joint measured. It is structurally a part of the body and is not movable independently of the body. The moving arm is the arm of the goniometer, which aligns with the mobile part of the joint measured. Neck flexion, extension, side bending and rotation will be assessed through it
2 secondary outcomes
NPRS (numeric pain rating scale)
Time frame: 4 weeks
NDI (neck disability index)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- 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.
Humera Mubashar, MS principal investigator
Riphah International University
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 and reciprocal inhibition in people with 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 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 17 Oct 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?
Contact Humera Mubashar, MS (+92 308 4157979, humera.mubashar@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goniometry (time frame: 4 weeks). 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 17 Oct 2023.