Neck PainNCT04679363
Comparison of Active Release Technique and Post Isometric Relaxation Technique on Pain and Functional Disability in Patient With Mechanical Neck Pain
A study testing Active release technique and Post isometric relaxation in people with Neck Pain, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Neck pain is one of the leading causes of musculoskeletal pain and disability in the world. Despite the prevalence, accompanying disabilities, low quality of life and economic burdens of mechanical neck pain, there is a gap in high quality evidence to effectively guide the conservative treatment of this patient… Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Active release technique and Post isometric relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2020to 15 Dec 2020
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with diagnosed mechanical neck pain
- Having NDI score of equal to or more than 10%
- Patients having neck pain less than 8 on NPRS
Who cannot join
- Patients having non-musculoskeletal injury
- Patients with nerve root compression
- Whiplash injuries
- History of cervical or thoracic spine surgery
- Patient on pain medication for neck pain
Trial locations and contacts
1 site in 1 country.
Ehab Azim, MS, PhD* contact
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University Institute of Rehabilitation Sciences.
Islamabad, Federal, 46000
Marwa Asim, 03335339457, marwa@fui.edu.pk
About this study
Neck pain is one of the leading causes of musculoskeletal pain and disability in the world. Despite the prevalence, accompanying disabilities, low quality of life and economic burdens of mechanical neck pain, there is a gap in high quality evidence to effectively guide the conservative treatment of this patient population. Active release technique (ART) is a soft tissue technique that focuses on removal of adhesions that build up in muscle due to overuse. ART can be used as both, as a diagnostic and treatment technique.
Limited literature is available on evaluation and treatment of neck pain by Active release technique in contrast to Post isometric release technique. This study fulfills this gap and will provide clinicians with an alternative treatment approach for mechanical neck pain.
Read the detailed description
Neck pain is defined by the Global Burden of health 2010 Study as "pain in the neck with or without pain referred into one or both upper limbs that lasts for at least one day" and is one of the leading causes of musculoskeletal pain and disability in the world. Neck pain can be classified into radicular neck pain and axial neck pain. Radicular pain radiates along the nerves and is caused by irritated nerves, whereas axial pain, also called as mechanical pain, is confined to one spot or region.
Despite the prevalence, accompanying disabilities, low quality of life and economic burdens of mechanical neck pain, there is a gap in high quality evidence to effectively guide the conservative treatment of this patient population. Physical therapy management of patients with neck pain mostly include the use of treatment approaches consisting of both manual therapies including cervical spine manipulation and/or mobilization and exercise programs training for treatment of symptoms of mechanical neck pain. Active release technique (ART) is a soft tissue technique that focuses on removal of adhesions that build up in muscle due to overuse. ART can be used as both, as a diagnostic and treatment technique. Post isometric relaxation technique (PIR) is a muscle energy technique that is mostly used to relax and lengthen stiff and shortened muscles. PIR uses the muscles own energy in form of isometric contractions to relax the muscle via autogenic inhibition.
A Bacon et al (2011) conducted a study on effects of ART on tension headaches and reported that ART improved the symptoms associated with tension headaches and showed good results. A study by S Joshi et al (2018) compared the effectiveness of ART and conventional physical therapy for management of upper cross syndrome and concluded that Active release technique with conventional therapy is more effective than conventional therapy alone in the management of upper cross syndrome. Similarly, S Tak et al (2013) investigated on the effects of ART on gluteus medius for chronic pain in lower back pain and concluded that ART was effective in reducing the pain symptoms in lower back.
Limited literature is available on evaluation and treatment of neck pain by Active release technique in contrast to Post isometric release technique. This study fulfills this gap and will provide clinicians with an alternative treatment approach for mechanical neck pain.
- Conditions
- Neck Pain
- Being tested
- Active release technique, Post isometric relaxation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active release techniqueOther
ART will be performed on upper trapezius and sternocleidomastoid, starting from 5 repetitions in 1st and 2nd week and progressing to 10 repetitions in 3rd week. ART will be performed in supine position with a pillow under knees. After the shortened area of the targeted muscle is identified, soft tissue mobilization with active movement and passive overpressure will be applied. The active movement in technique will be from shortened position of muscle to lengthened position.
Post isometric relaxationOther
PIR will be performed on upper trapezius and sternocleidomastoid muscles, starting from 5 repetitions in 1st and 2nd week and progressing to 10 repetitions in 3rd week. The patient will be instructed to move the ear towards the shoulder of the affected side, against the resistance of the therapist's hands with minimum force (only 20% of their total force). The patient will be instructed to perform isometric contraction of the affected side along with inhalation and position for 10 seconds. Then the patient will exhale completely and relax. During this relaxation phase head and neck are taken further away from ipsilateral shoulder and ipsilateral shoulder is pushed downward until next restriction is met.
| Study group | Role | What they receive |
|---|---|---|
| Active release technique group | Experimental | Active release technique group (ART group) will receive Oscillatory mobilization with active release technique. Treatment will be provided for 2 session/week for 3 weeks with 40 minutes/session. Patient will be assessed at baseline and after 3rd week of intervention. Receives: Other: Active release technique |
| Post isometric relaxation group | Experimental | Post isometric relaxation group (PIR group) will receive Oscillatory mobilization with post isometric relaxation technique. Treatment will be provided for 2 session/week for 3 weeks with 40 minutes/session. Patient will be assessed at baseline and after 3rd week of intervention. Receives: Other: Post isometric relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating scale
The Numeric pain rating scale is a tool used for measurement of pain. The Numeric pain rating scale is a tool used for measurement of pain. It is 11-point scale from 0-10, 0 = no pain and 10 = most intense pain imaginable. Reliability for NPRS is ICC = 0.67.
Measured: 3 weeks
Secondary outcomes (2)
Algometry
Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold
Measured: 3 weeks
Cervical Range of Motion
The cervical range of motion instrument (CROM) is a device to take objective measurements of cervical ranges. The reliability for CROM is 0.63-0.90.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start15 Sep 2020
- Primary completion25 Nov 2020
- Study completion15 Dec 2020 (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 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679363
- Sponsor's protocol ID
- FUI/CTR/2020/10
- Status last verified
- Dec 2020
- First submitted
- 23 Nov 2020
- Last updated
- 22 Dec 2020
- 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 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Active Release Technique and Post Isometric Relaxation Technique on Pain and Functional Disability in Patient With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT04679363
- Acronym / sponsor ID
- FUI/CTR/2020/10
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 22 Dec 2020 (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 one of the leading causes of musculoskeletal pain and disability in the world. Despite the prevalence, accompanying disabilities, low quality of life and economic burdens of mechanical neck pain, there is a gap in high quality evidence to effectively guide the conservative treatment of this patient population. Active release technique (ART) is a soft tissue technique that focuses on removal of adhesions that build up in muscle due to overuse. ART can be used as both, as a diagnostic and treatment technique.
Limited literature is available on evaluation and treatment of neck pain by Active release technique in contrast to Post isometric release technique. This study fulfills this gap and will provide clinicians with an alternative treatment approach for mechanical neck pain.
Detailed description
Neck pain is defined by the Global Burden of health 2010 Study as "pain in the neck with or without pain referred into one or both upper limbs that lasts for at least one day" and is one of the leading causes of musculoskeletal pain and disability in the world. Neck pain can be classified into radicular neck pain and axial neck pain. Radicular pain radiates along the nerves and is caused by irritated nerves, whereas axial pain, also called as mechanical pain, is confined to one spot or region.
Despite the prevalence, accompanying disabilities, low quality of life and economic burdens of mechanical neck pain, there is a gap in high quality evidence to effectively guide the conservative treatment of this patient population. Physical therapy management of patients with neck pain mostly include the use of treatment approaches consisting of both manual therapies including cervical spine manipulation and/or mobilization and exercise programs training for treatment of symptoms of mechanical neck pain. Active release technique (ART) is a soft tissue technique that focuses on removal of adhesions that build up in muscle due to overuse. ART can be used as both, as a diagnostic and treatment technique. Post isometric relaxation technique (PIR) is a muscle energy technique that is mostly used to relax and lengthen stiff and shortened muscles. PIR uses the muscles own energy in form of isometric contractions to relax the muscle via autogenic inhibition.
A Bacon et al (2011) conducted a study on effects of ART on tension headaches and reported that ART improved the symptoms associated with tension headaches and showed good results. A study by S Joshi et al (2018) compared the effectiveness of ART and conventional physical therapy for management of upper cross syndrome and concluded that Active release technique with conventional therapy is more effective than conventional therapy alone in the management of upper cross syndrome. Similarly, S Tak et al (2013) investigated on the effects of ART on gluteus medius for chronic pain in lower back pain and concluded that ART was effective in reducing the pain symptoms in lower back.
Limited literature is available on evaluation and treatment of neck pain by Active release technique in contrast to Post isometric release technique. This study fulfills this gap and will provide clinicians with an alternative treatment approach for mechanical neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active release technique group | Experimental | Other: Active release techniqueActive release technique group (ART group) will receive Oscillatory mobilization with active release technique. Treatment will be provided for 2 session/week for 3 weeks with 40 minutes/session. Patient will be assessed at baseline and after 3rd week of intervention. |
| Post isometric relaxation group | Experimental | Other: Post isometric relaxationPost isometric relaxation group (PIR group) will receive Oscillatory mobilization with post isometric relaxation technique. Treatment will be provided for 2 session/week for 3 weeks with 40 minutes/session. Patient will be assessed at baseline and after 3rd week of intervention. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with diagnosed mechanical neck pain
- Having NDI score of equal to or more than 10%
- Patients having neck pain less than 8 on NPRS
Key exclusion criteria (5 listed)
- Patients having non-musculoskeletal injury
- Patients with nerve root compression
- Whiplash injuries
- History of cervical or thoracic spine surgery
- Patient on pain medication for neck pain
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 |
|---|---|---|
| Active release techniqueART will be performed on upper trapezius and sternocleidomastoid, starting from 5 repetitions in 1st and 2nd week and progressing to 10 repetitions in 3rd week. ART will be performed in supine position with a pillow under knees. After the shortened area of the targeted muscle is identified, soft tissue mobilization with active movement and passive overpressure will be applied. The active movement in technique will be from shortened position of muscle to lengthened position. | Other | Active release technique group |
| Post isometric relaxationPIR will be performed on upper trapezius and sternocleidomastoid muscles, starting from 5 repetitions in 1st and 2nd week and progressing to 10 repetitions in 3rd week. The patient will be instructed to move the ear towards the shoulder of the affected side, against the resistance of the therapist's hands with minimum force (only 20% of their total force). The patient will be instructed to perform isometric contraction of the affected side along with inhalation and position for 10 seconds. Then the patient will exhale completely and relax. During this relaxation phase head and neck are taken further away from ipsilateral shoulder and ipsilateral shoulder is pushed downward until next restriction is met. | Other | Post isometric relaxation group |
Primary outcome
Numeric Pain Rating scale
Time frame: 3 weeks
The Numeric pain rating scale is a tool used for measurement of pain. The Numeric pain rating scale is a tool used for measurement of pain. It is 11-point scale from 0-10, 0 = no pain and 10 = most intense pain imaginable. Reliability for NPRS is ICC = 0.67.
2 secondary outcomes
Algometry
Time frame: 3 weeks
Cervical Range of Motion
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- 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.
Ehab Azim, MS, PhD* contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active release technique and Post isometric relaxation 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 3 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: status not confirmed, as of the sponsor's last update on 22 Dec 2020. 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 Marwa Asim, MS (03335339457, marwa@fui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating scale (time frame: 3 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 22 Dec 2020; AzTrials last refreshed its copy on 2 Nov 2026.