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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04679363
Other study ID # FUI/CTR/2020/10
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date December 15, 2020

Study information

Verified date December 2020
Source Foundation University Islamabad
Contact Marwa Asim, MS
Phone 03335339457
Email marwa@fui.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date December 15, 2020
Est. primary completion date November 25, 2020
Accepts healthy volunteers No
Gender All
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Active release technique
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 relaxation
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.

Locations

Country Name City State
Pakistan Foundation University Institute of Rehabilitation Sciences. Islamabad Federal

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 weeks
Secondary Algometry Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold 3 weeks
Secondary 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. 3 weeks
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