Neck PainNCT03136250
Effects of Autogenic and Reciprocal Inhibition, Muscle Energy Techniques in the Management of Mechanical Neck Pain
A study testing Group B (Autogenic Inhibition - PIR + Standard treatment) and Group C (Reciprocal Inhibition - RI + Standard treatment) in people with Neck Pain, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Neck pain is among the most common musculoskeletal disorders worldwide and is an important public health issue in terms of personal wellbeing. Prevalence of neck pain show excessive variations, with a point prevalence varying between 6% and 22%, and one year prevalence ranging between 1.5-75%. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Group B (Autogenic Inhibition - PIR + Standard treatment) and Group C (Reciprocal Inhibition - RI + Standard treatment)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Apr 2017to 30 Dec 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years;
- Neck pain on NPRS 4 to 8 (moderate cases);
- Subacute or chronic cases (4 to 12 weeks).
- Decreased or painful Cervical range of motion (CROM)
Who cannot join
- Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection);
- History of cervical spine surgery in previous 12 months;
- History of trauma or fractures in cervical spine;
- Signs of cervical radiculopathy or myelopathy; and
- Vascular syndromes such as VBI
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University Institute of Rehabilitation Sciences
Islamabad
About this study
Neck pain is among the most common musculoskeletal disorders worldwide and is an important public health issue in terms of personal wellbeing. Prevalence of neck pain show excessive variations, with a point prevalence varying between 6% and 22%, and one year prevalence ranging between 1.5-75%. Neck pain like all other mechanical disorders leads to pain, disability and decreased range of motion (ROM). Stretching is a very common exercise performed by sportsmen, elderly, in physical therapy and rehabilitation patients, thus practiced in all sorts of fitness programs. The major types of stretching included in the literature are static, dynamic and pre-contraction stretching; of which static stretching is the conventional type of stretching. The different types of pre-contraction stretching include Proprioceptive Neuromuscular Facilitation (PNF) stretching, Post Isometric Relaxation (PIR), Post Facilitation stretch (PFS) and Active Isolated Stretch (AIS). Pre-contraction stretching is also considered a part of Muscle Energy Technique (MET). Recently MET and pre-contraction stretching have been shown to have significant superiority over conventional stretching in management of mechanical neck pain, but the evidence is currently lacking regarding which of the two pre-contraction stretching protocols, namely autogenic and reciprocal inhibition is more effective than the other. A RCT will be conducted in order to find and compare the effectiveness of conventional stretching and pre-contraction stretching (autogenic inhibition and reciprocal inhibition). One Control group (conventional group) and two Experimental groups (Experimental Group A - Autogenic Inhibition \& Experimental Group B - Reciprocal Inhibition) will be formed. The participants will be recruited in the study if they meet the inclusion criteria using consecutive sampling from Fauji Foundation Hospital and randomized into the three respective groups. All the groups will receive the gold standard treatment for chronic neck pain including mobilization and modalities. In addition to the gold standard treatment the participants will receive specific stretching protocol based on their interventional group
- Conditions
- Neck Pain
- Being tested
- Group A (Control Group - Static Stretching + Standard Treatment), Group B (Autogenic Inhibition - PIR + Standard treatment), Group C (Reciprocal Inhibition - RI + Standard treatment)
- Keywords
- Muscle Energy Techniques, Autogenic Inhibition, Reciprocal Inhibition, Stretching, Range of Motion, Muscle Strength, VAS, Neck Disability Index, NDI
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (Control Group - Static Stretching + Standard Treatment)Other
- Conventional Gold Standard treatment (Manual Therapy + Modalities) Conventional Static Stretching 15-30 seconds hold 3-5 repetitions (Page P, 2012) for Ant/Middle/Posterior Scaleni, Sternocleidomastoid, Levator Scapulae and Upper Trapezius Muscles.
Group B (Autogenic Inhibition - PIR + Standard treatment)Other
- Conventional Gold Standard treatment (Manual Therapy + Modalities) Post Isometric Relaxation MET (3-5 reps) for Ant/Middle/Posterior Scaleni, Sternocleidomastoid, Levator Scapulae and Upper Trapezius Muscles. (Chaitow L, 2006)
Group C (Reciprocal Inhibition - RI + Standard treatment)Other
- Conventional Gold Standard treatment (Manual Therapy + Modalities) Reciprocal Inhibition MET (3-5 reps) for Ant/Middle/Posterior Scaleni, Sternocleidomastoid,Levator Scapulae and Upper Trapezius Muscles (Chaitow L, 2006)
| Study group | Role | What they receive |
|---|---|---|
| Group A (Control Group - Static Stretching) | Active comparator | (Control Group - Static Stretching + Standard Treatment) Receives: Other: Group A (Control Group - Static Stretching + Standard Treatment) |
| Group B (Autogenic Inhibition MET) | Experimental | (Autogenic Inhibition - PIR + Standard treatment) Receives: Other: Group B (Autogenic Inhibition - PIR + Standard treatment) |
| Group C (Reciprocal Inhibition MET) | Experimental | (Reciprocal Inhibition - RI + Standard treatment) Receives: Other: Group C (Reciprocal Inhibition - RI + Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (Numeric Pain Rating Scale) - Change is being assessed
To measure the pre and post patient's perception of pain
Measured: Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
Cervical Range of Motion (CROM) - Change is being assessed
To measure patient's improvement in cervical range of motion
Measured: Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
Neck Disability Index (NDI) - Change is being assessed
to measure patient's pre and post functional disability
Measured: Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
Cervical Isometric Muscle Strength (Modified Sphygmomanometer dynamometry) - Change is being assessed
To measure patient's improvement in Isometric Muscle Strength
Measured: Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start11 Apr 2017
- Primary completion30 Nov 2017
- Study completion30 Dec 2017
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 Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized Controlled trial will be conducted in order to find and compare the effectiveness of conventional stretching and MET stretching (autogenic inhibition and reciprocal inhibition). One Control group (conventional group) and two Experimental groups (Experimental Group A - Autogenic Inhibition \& Experimental Group B - Reciprocal Inhibition) will be formed. The participants will be recruited in the study if they meet the inclusion criteria using consecutive sampling from Fauji Foundation Hospital and randomized into the three respective groups. All the groups will receive the gold standard treatment for chronic neck pain including mobilization and modalities. In addition to the gold standard treatment the participants will receive specific stretching protocol based on their interventional group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Osama, DPT, MS-OMPT, CHPE, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136250
- Sponsor's protocol ID
- FUI/CTR/2017/1
- Status last verified
- Dec 2017
- First submitted
- 10 Apr 2017
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Autogenic and Reciprocal Inhibition, Muscle Energy Techniques in the Management of Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT03136250
- Acronym / sponsor ID
- FUI/CTR/2017/1
- Conditions
- Neck Pain
- Keywords
- Muscle Energy Techniques, Autogenic Inhibition, Reciprocal Inhibition, Stretching, Range of Motion, Muscle Strength, VAS, Neck Disability Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 2 May 2017 (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.
Neck pain is among the most common musculoskeletal disorders worldwide and is an important public health issue in terms of personal wellbeing. Prevalence of neck pain show excessive variations, with a point prevalence varying between 6% and 22%, and one year prevalence ranging between 1.5-75%. Neck pain like all other mechanical disorders leads to pain, disability and decreased range of motion (ROM). Stretching is a very common exercise performed by sportsmen, elderly, in physical therapy and rehabilitation patients, thus practiced in all sorts of fitness programs. The major types of stretching included in the literature are static, dynamic and pre-contraction stretching; of which static stretching is the conventional type of stretching. The different types of pre-contraction stretching include Proprioceptive Neuromuscular Facilitation (PNF) stretching, Post Isometric Relaxation (PIR), Post Facilitation stretch (PFS) and Active Isolated Stretch (AIS). Pre-contraction stretching is also considered a part of Muscle Energy Technique (MET). Recently MET and pre-contraction stretching have been shown to have significant superiority over conventional stretching in management of mechanical neck pain, but the evidence is currently lacking regarding which of the two pre-contraction stretching protocols, namely autogenic and reciprocal inhibition is more effective than the other. A RCT will be conducted in order to find and compare the effectiveness of conventional stretching and pre-contraction stretching (autogenic inhibition and reciprocal inhibition). One Control group (conventional group) and two Experimental groups (Experimental Group A - Autogenic Inhibition \& Experimental Group B - Reciprocal Inhibition) will be formed. The participants will be recruited in the study if they meet the inclusion criteria using consecutive sampling from Fauji Foundation Hospital and randomized into the three respective groups. All the groups will receive the gold standard treatment for chronic neck pain including mobilization and modalities. In addition to the gold standard treatment the participants will receive specific stretching protocol based on their interventional group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized Controlled trial will be conducted in order to find and compare the effectiveness of conventional stretching and MET stretching (autogenic inhibition and reciprocal inhibition). One Control group (conventional group) and two Experimental groups (Experimental Group A - Autogenic Inhibition \& Experimental Group B - Reciprocal Inhibition) will be formed. The participants will be recruited in the study if they meet the inclusion criteria using consecutive sampling from Fauji Foundation Hospital and randomized into the three respective groups. All the groups will receive the gold standard treatment for chronic neck pain including mobilization and modalities. In addition to the gold standard treatment the participants will receive specific stretching protocol based on their interventional group.
| Arm | Type | Receives |
|---|---|---|
| Group A (Control Group - Static Stretching) | Active comparator | Other: Group A (Control Group - Static Stretching + Standard Treatment)(Control Group - Static Stretching + Standard Treatment) |
| Group B (Autogenic Inhibition MET) | Experimental | Other: Group B (Autogenic Inhibition - PIR + Standard treatment)(Autogenic Inhibition - PIR + Standard treatment) |
| Group C (Reciprocal Inhibition MET) | Experimental | Other: Group C (Reciprocal Inhibition - RI + Standard treatment)(Reciprocal Inhibition - RI + Standard treatment) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 70 years;
- Neck pain on NPRS 4 to 8 (moderate cases);
- Subacute or chronic cases (4 to 12 weeks).
- Decreased or painful Cervical range of motion (CROM)
Key exclusion criteria (5 listed)
- Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection);
- History of cervical spine surgery in previous 12 months;
- History of trauma or fractures in cervical spine;
- Signs of cervical radiculopathy or myelopathy; and
- Vascular syndromes such as VBI
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 |
|---|---|---|
| Group A (Control Group - Static Stretching + Standard Treatment)o Conventional Gold Standard treatment (Manual Therapy + Modalities) Conventional Static Stretching 15-30 seconds hold 3-5 repetitions (Page P, 2012) for Ant/Middle/Posterior Scaleni, Sternocleidomastoid, Levator Scapulae and Upper Trapezius Muscles. | Other | Group A (Control Group - Static Stretching) |
| Group B (Autogenic Inhibition - PIR + Standard treatment)o Conventional Gold Standard treatment (Manual Therapy + Modalities) Post Isometric Relaxation MET (3-5 reps) for Ant/Middle/Posterior Scaleni, Sternocleidomastoid, Levator Scapulae and Upper Trapezius Muscles. (Chaitow L, 2006) | Other | Group B (Autogenic Inhibition MET) |
| Group C (Reciprocal Inhibition - RI + Standard treatment)o Conventional Gold Standard treatment (Manual Therapy + Modalities) Reciprocal Inhibition MET (3-5 reps) for Ant/Middle/Posterior Scaleni, Sternocleidomastoid,Levator Scapulae and Upper Trapezius Muscles (Chaitow L, 2006) | Other | Group C (Reciprocal Inhibition MET) |
Primary outcome
Pain (Numeric Pain Rating Scale) - Change is being assessed
Time frame: Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
To measure the pre and post patient's perception of pain
Cervical Range of Motion (CROM) - Change is being assessed
Time frame: Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
To measure patient's improvement in cervical range of motion
Neck Disability Index (NDI) - Change is being assessed
Time frame: Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
to measure patient's pre and post functional disability
Cervical Isometric Muscle Strength (Modified Sphygmomanometer dynamometry) - Change is being assessed
Time frame: Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)
To measure patient's improvement in Isometric Muscle Strength
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 8 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Neck Pain
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Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
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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.
Muhammad Osama, DPT, MS-OMPT, CHPE principal investigator
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group B (Autogenic Inhibition - PIR + Standard treatment) and Group C (Reciprocal Inhibition - RI + Standard treatment) in people with Neck Pain, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 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 8 Feb 2018. 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?
Pain (Numeric Pain Rating Scale) - Change is being assessed (time frame: Pre-treatment (First day before treatment), Immediate Follow Up (After 1st treatment session) & Follow Up (After 5 days of Treatment)). 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?
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 8 Feb 2018.