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Trigger Point Pain, MyofascialNCT04747899

Positional Release Technique for Myofascial Trigger Points of the Upper Trapezius

A study testing Positional release technique and Traditional physical therapy in people with Trigger Point Pain, Myofascial, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this research is to find the effects of Positional Release Technique (PRT) on pain, range of motion and neck disability index in patients with myofascial trigger points (MTRPs) of the upper trapezius with forward head posture (FHP). Read more about this study

Who is it for?
Ages 18 to 45 years, men only
Conditions the study is for
Trigger Point Pain, Myofascial
What is being tested?
Positional release technique and Traditional physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
29 Jan 2021to 29 Jul 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 18 to 45 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Pain intensity of at least 3 on VAS.
  • Presence of palpable taut band \& at least one active trigger point in upper trapezius. Diagnosis of trigger point will confirm by following criteria given by Travel \& Simon.
  • CVA less than 50 degrees while standing.
  • At least 6 hours in sitting position and work via computers per day

Who cannot join

  • Diagnosis of fibromyalgia \& RA.
  • Diagnosis of cervical Radiculopathy or Myelopathy
  • History of a whiplash injury
  • History of cervical spine and shoulder surgery
  • Having undergone Trigger point therapy within the past month prior to the study
  • Drug intake (anti-inflammatory medication during treatment sessions)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • THQ Civil Hospital

    Wazirabad, Punjab Province, 52000

Other trials in Pakistan

About this study

Official title: Effects of Positional Release Technique for Myofascial Trigger Points of the Upper Trapezius With Forward Head Posture

The aim of this research is to find the effects of Positional Release Technique (PRT) on pain, range of motion and neck disability index in patients with myofascial trigger points (MTRPs) of the upper trapezius with forward head posture (FHP). A Randomized control trial is conducted at Tehsil Head Quater (THQ) Civil hospital Wazirabad. The sample size is calculated through open epi tool is 32. The subjects are divided in two groups, 16 participants in experimental group and 16 in control group. The study duration is of six months. Sampling technique applied is purposive non probability sampling technique. Only 18-45 years participants with myofascial trigger points of the upper trapezius is included. Tools used in the study are Visual analog scale (VAS), Pain Pressure Threshold (PPT), active cervical contra-lateral flexion (ACLF), Cranio vertebral angle (CVA) and neck disability index (NDI). Data analyzed through Statistical Package for the Social Sciences (SPSS) version 23.

Read the detailed description

Muscular and skeletal structures can change into an incorrect shape due to a reduction in physical activity and inappropriate posture habits in daily living. Kong YS et al defined Forward head posture (FHP) as a posture that adopts upper cervical extension and lower cervical flexion. The center of gravity of the head in this posture is positioned at the front rather than the vertebral body weight.

FHP weakens the deep cervical flexor muscle, the mid thoracic rhomboid muscle for scapular retraction, and the mid and lower trapezius muscles. FHP also shortens the pectoralis major and neck extension muscles. Upper trapezius muscle activity is increased more in FHP than in correct anatomic positions, and most patients complain of pain from muscle overuse.

The craniovertebral angle (CVA) is defined as an angle made by the intersection of a line joining the midpoint of the tragus of ear to the skin overlying the C7 spinous process and a horizontal line passing through the C7 spinous process. There is a correlation between FHP, neck pain, and CVA. One of the studies reported that subjects having smaller CVA had FHP and were prone to have increased severity of neck pain.

D'souza CJ et al stated that positional Release Therapy (PRT) is a noninvasive treatment which can be used in conjunction with several electrical modalities. In this technique, in order to facilitate restoration of normal tissue length and to treat excessive muscle tension or spasm, tissues are placed in a Position of comfort for a brief period (90 sec) to resolve the associated dysfunction.

In 2017 a study conducted which shows that PRT has beneficial effects on myofascial trigger points (MTrPs). In this regard, Kelencz et al. reported that PRT is effective in reducing pain and muscle tension among patients with upper-trapezius MTrPs. Amini A et al studied on 30 female university students, who were identified with latent MTrPs of the upper trapezius, according to the results, both Manual Passive Muscle Shortening (MPMS) and PRT were effective techniques in immediate pain relief of upper-trapezius MTrPs.

Kojidi MM et al concluded that Positional Release Therapy was found to be effective in reducing pain and increasing Pressure pain threshold in three treatment sessions in 19-45 year-old female computer users with at least 2 h of work and with latent upper trapezius trigger points. Mohamadi M et al state that PRT is a potential treatment option with no reported side effects for patients with Tension Type Headache (TTH).

In general, PRT and Therapeutic Massage were both successful at decreasing MTrP sensitivity and stiffness. However, there appeared to be a slight benefit for pain reduction with PRT up to 2 days post treatment.

Varshney K et al concluded that the patients who received positional release therapy along with moist heat pack has more impact on pain and disability as compared to those received deep transverse friction massage along with moist heat pack follow-up 4 weeks protocol.

Study concluded that the difference from 1st to 21th day in VAS \&NDI score which shows that Positional release therapy (PRT) is more effective than conventional Physiotherapeutic intervention in order to decrease pain and disability in patients with no-specific neck pain.

Manzoor S et al treated a 62 year female who was suffering tension type headache from last 14 months was treated by combined positional release therapy and ischemic compression in 6 sessions, concluded that combination of positional stretch and Ischemic compression is effective treatment for patients with trigger points in cervical muscles, most commonly upper trapezius and sternocleidomastoid causing cervicogenic headache.

There is poor evidence regarding the effects of PRT on MTRPs with forward head posture on Cranio-vertebral angle. So this study aims to find the effectiveness of PRT for myofascial trigger points of the upper trapezius with forward head posture as there is less literature available about the gender based effect of PRT, as most of the studies have done on female population, basically this study will target the effect of PRT on male computer users with FHP on Pain, ROM, disability and Cranio vertebral angle.

Being tested
Positional release technique, Traditional physical therapy
Keywords
myofascial trigger points of the upper trapezius, Positional Release technique, Neck Pain Disability index, Cranio vertebral angle
Medical subject headings
Myofascial Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positional release techniqueOther

    Experimental group is given Positional Release Technique along with the hot pack, muscle stretching and posture correction.

    Positional release technique position will maintained for almost 90 seconds. This technique will be repeated for three times each session, with 10 sec relaxation, 3 days/week.

    Upper trapezius stretching 5 repetitions×1 set, 3 days/ week. Total of 3 sessions were given each consisting of 30 min.

    Posture correction in ADLs as well as in working place by advising correct sitting posture, the participants will advised to relieve muscle tension after every 20-30 minutes of work by getting up; stretching the arm, shoulder, neck, and back muscles.

  • Traditional physical therapyOther

    Hot pack for 15-mins. Upper trapezius stretching 5 repetitions×1 set, 3 days/ week. Total of 3 sessions are given each consisting of 30 min.

    Posture correction in ADLs as well as in working place by advising correct sitting posture, the participants will advised to relieve muscle tension after every 20-30 minutes of work by getting up; stretching the arm, shoulder, neck, and back muscles.

Study groups in NCT04747899
Study groupRoleWhat they receive
Traditional physical therapyActive comparatorTraditional physical therapy ,Hot Pack, Muscle Stretching and Posture correction
Receives: Other: Traditional physical therapy
Positional Release TechniqueExperimentalExperimental group is given Positional Release Technique along with the hot pack, muscle stretching and posture correction.
Receives: Other: Positional release technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neck disability index

    Changes from base line Northwick disability index was developed first in Northwick Park hospital, England. It was designed to measure the neck pain and disability over time. It consists of 10, five parts sections. At the end, score is calculated by dividing the obtained score by total (50) multiplied by 100. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'.

    Measured: 12th day

Secondary outcomes (4)
  1. Visual analog scale

    Changes from base Line Visual Analog Scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.

    Measured: 12th day

  2. ROM Active Contra Lateral Flexion (ACLF)

    Changes from the Baseline ROM range of Motion of Active Contra Lateral Flexion (ACLF) is taken with the Help of Goniometry. Subjects sit upright and laterally flex their head towards the opposite side of involvement and the motion was stopped once the available ROM was completed.

    Measured: 12th day

  3. Pain Pressure Threshold (PPT

    Changes from the Baseline Pain Pressure Threshold (PPT) was taken with the Help of Algometer.

    Measured: 12th day

  4. Cranio vertebral angle (CVA)

    Changes from the baseline Cranio vertebral angle is measured by intersection of a horizontal line passing through the C7 spinous process and a line joining the midpoint of the tragus of the ear to the skin overlying the C7 spinous process.

    Measured: 12th day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2021
  2. Study start29 Jan 2021
  3. Primary completion29 Jul 2021
  4. Study completion29 Jul 2021

Resources

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04747899
Sponsor's protocol ID
REC/00865 Asad Ullah
Status last verified
Apr 2022
First submitted
5 Feb 2021
Last updated
12 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee DY, Nam CW, Sung YB, Kim K, Lee HY. Changes in rounded shoulder posture and forward head posture according to exercise methods. J Phys Ther Sci. 2017 Oct;29(10):1824-1827. doi: 10.1589/jpts.29.1824. Epub 2017 Oct 21.

    PubMed 29184298
  • Kong YS, Kim YM, Shim JM. The effect of modified cervical exercise on smartphone users with forward head posture. J Phys Ther Sci. 2017 Feb;29(2):328-331. doi: 10.1589/jpts.29.328. Epub 2017 Feb 24.

    PubMed 28265167
  • Kim SY, Koo SJ. Effect of duration of smartphone use on muscle fatigue and pain caused by forward head posture in adults. J Phys Ther Sci. 2016 Jun;28(6):1669-72. doi: 10.1589/jpts.28.1669. Epub 2016 Jun 28.

    PubMed 27390391
  • Sikka I, Chawla C, Seth S, Alghadir AH, Khan M. Effects of Deep Cervical Flexor Training on Forward Head Posture, Neck Pain, and Functional Status in Adolescents Using Computer Regularly. Biomed Res Int. 2020 Oct 5;2020:8327565. doi: 10.1155/2020/8327565. eCollection 2020.

    PubMed 33083487
  • Mohammadi Kojidi M, Okhovatian F, Rahimi A, Baghban AA, Azimi H. The influence of Positional Release Therapy on the myofascial trigger points of the upper trapezius muscle in computer users. J Bodyw Mov Ther. 2016 Oct;20(4):767-773. doi: 10.1016/j.jbmt.2016.04.006. Epub 2016 Apr 7.

    PubMed 27814857
  • Amini A, Goljaryan S, Shakouri SK, Mohammadimajd E. The Effects of Manual Passive Muscle Shortening and Positional Release Therapy on Latent Myofascial Trigger Points of the Upper Trapezius: A Double-Blind Randomized Clinical Trial. Iranian Red Crescent Medical Journal. 2017 Sep;19(9).

  • Varshney K, Raghav S, Singh A. A study to compare the effect of positional release technique (PRT) versus deep transverse friction massage (DTFM) on pain and disability in patients with mechanical neck pain.

  • Varshney K, Raghav S, Singh A, Meena R K, Sharma S. Short term effect of Positional Release Therapy versus conventional Physiotherapeutic programme on pain and disability among undergraduate Physiotherapy students with nonspecific neck pain: A Pilot Study. Subharti J of Interdisciplinary Research, April 2019; Vol. 2: Issue 1, 7-11.

  • Manzoor S, Afzal F. Effect of Combined positional stretch and ischemic compression on Cervicogenic Headache. Headache.;1:2.

Questions about this trial

What is this clinical trial studying?

A study testing Positional release technique and Traditional physical therapy in people with Trigger Point Pain, Myofascial, 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 4 inclusion and 6 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 12 Apr 2022. 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?

Neck disability index (time frame: 12th day). 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 NCT04747899, which also lists 9 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 12 Apr 2022.

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