NCT04823013

Brief Summary

This study aimed to compare the efficacy of ischemic compression and two different application methods of high power pain threshold ultrasound techniques on latent trigger point treatment. Asymptomatic subjects divided into three groups. First group took high power pain threshold ultrasound in which the intensity is kept constant at the pain level; second group took high power pain threshold ultrasound which the intensity is kept constant at half the pain level and third group took ischemic compression. All participants were asked to complete the questionnaires, which assessed pain, psychological factors and disability before treatment, after 1 week and 1 month follow-up. After each participants completed the questionnaire, the physical therapist evaluated the MTrPs. MTrPs assessment was performed before treatment, immediately after treatment, after 1 week and 1 month follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 24, 2021

Last Update Submit

March 26, 2021

Conditions

Keywords

high power pain threshold ultrasoundischemic compressionpaintrigger pointspain pressure threshold

Outcome Measures

Primary Outcomes (13)

  • Pain intensity

    Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels

    Pain intensity was measured using visual analog scale (VAS) before the treatment (0-10 numeric pain rating scale, with 0 indicating no pain and 10 severe pain)

  • Beck Depression Inventory

    Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.

    Depression was assessed using the Beck Depression Inventory (BDI) before the treatment. BDI comprises 21 items, each of which is rated between 0 and 3 on a 4-point Likert Scale. The total score ranges from 0 to 63 points.

  • Neck Pain and Disability Scale

    A disability is any condition of the body or mind that makes it more difficult for the person with the condition to do certain activities (activity limitation) and interact with the world around them.

    Disability was evaluated by Neck Pain and Disability Scale (NPAD) before the treatment. The scale progresses from 0 to 5, increasing the limitation. the total NPAD score, which ranges from 0 to 100 points.

  • Myofascial trigger points assessment

    Myofascial trigger points (MTrPs) have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena

    The MTrPs assesment was made with palpation by the physical therapist. The therapist used an algometer. The number of MTrPs and pain pressure threshold values were evaluated before treatment. PPT is a safe outcome measure to evaluate pain sensitivity.

  • Myofascial trigger points assessment

    Myofascial trigger points (MTrPs) have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena

    The MTrPs assesment was made with palpation by the physical therapist. The therapist used an algometer. The number of MTrPs and pain pressure threshold values were evaluated immediately after the treatment.

  • Pain intensity

    Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels

    Pain intensity was measured using visual analog scale (VAS) at one week after the treatment (0-10 numeric pain rating scale, with 0 indicating no pain and 10 severe pain)

  • Beck Depression Inventory

    Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.

    Depression was assessed using the Beck Depression Inventory (BDI) at one week after the treatment. BDI comprises 21 items, each of which is rated between 0 and 3 on a 4-point Likert Scale. The total score ranges from 0 to 63 points.

  • Neck Pain and Disability Scale

    A disability is any condition of the body or mind that makes it more difficult for the person with the condition to do certain activities (activity limitation) and interact with the world around them.

    Disability was evaluated by Neck Pain and Disability Scale (NPAD) at one week after the treatment. The scale progresses from 0 to 5, increasing the limitation. the total NPAD score, which ranges from 0 to 100 points.

  • Myofascial trigger points assessment

    Myofascial trigger points (MTrPs) have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena

    The MTrPs assesment was made with palpation by the physical therapist. The therapist used an algometer. Pain pressure threshold values were evaluated at one week after the treatment.

  • Pain intensity

    Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels

    Pain intensity was measured using visual analog scale (VAS) at one month after the treatment (0-10 numeric pain rating scale, with 0 indicating no pain and 10 severe pain)

  • Beck Depression Inventory

    Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.

    Depression was assessed using the Beck Depression Inventory (BDI) at one month after the treatment. BDI comprises 21 items, each of which is rated between 0 and 3 on a 4-point Likert Scale. The total score ranges from 0 to 63 points.

  • Neck Pain and Disability Scale

    A disability is any condition of the body or mind that makes it more difficult for the person with the condition to do certain activities (activity limitation) and interact with the world around them.

    Disability was evaluated by Neck Pain and Disability Scale (NPAD) at one month after the treatment. The scale progresses from 0 to 5, increasing the limitation. the total NPAD score, which ranges from 0 to 100 points.

  • Myofascial trigger points assessment

    Myofascial trigger points (MTrPs) have been defined as discrete and hyperirritable areas located within a taut band of skeletal muscle or fascia which when compressed produce pain, tenderness, dysfunction and autonomic phenomena

    The MTrPs assesment was made with palpation by the physical therapist. The therapist used an algometer. Pain pressure threshold values were evaluated at one month after the treatment.

Study Arms (3)

high power pain threshold ultrasound which the dose was kept constant group (HPPT-US 1)

EXPERIMENTAL

Participants in HPPT-US 1 group received one session of HPPT-US treatment which the dose was kept constant. The technique delivers sound waves directly to the myofascial trigger points and results in immediate pain relief.

Other: high power pain threshold ultrasound which the dose was kept constant

high power pain threshold ultrasound which the dose reduced to one half group (HPPT-US 2)

EXPERIMENTAL

Participants in HPPT-US 2 group received one session of HPPT-US treatment which the dose reduced to one half. The technique delivers sound waves directly to the myofascial trigger points and results in immediate pain relief.

Other: high power pain threshold ultrasound which the dose reduced to one half

ischemic compression group

EXPERIMENTAL

Participants in IC group received one session of ischemic compression therapy. Ischemic compression is a therapy technique used in manual therapy, where blockage of blood in an area of the body is deliberately made, so that a resurgence of local blood flow will occur upon release.

Other: ischemic compression

Interventions

Participants in HPPT-US 1 group received the HPPT-US treatment. The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, and then moved the US transducer in a circle without the change of the intensity for 15 s. The procedure was repeated 3 times. The patients were asked whether serious pain or any abnormal sensation was felt during HPPT-US. The intensity was varied from 0.5 to 1.2 W/ cm².

high power pain threshold ultrasound which the dose was kept constant group (HPPT-US 1)

Participants in HPPT-US 2 group also received the HPPT-US treatment. The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, then reduced the dose half and moved the US transducer in a circle for 15 s. The procedure was repeated 3 times. The patients were asked whether serious pain or any abnormal sensation was felt during HPPT-US. The intensity was varied from 0.5 to 1.2 W/ cm².

high power pain threshold ultrasound which the dose reduced to one half group (HPPT-US 2)

Participants in IC group received ischemic compression therapy. The technique was applied in the sitting position to participants. Ischemic compression was performed by compressing trigger points identified by palpation with tolerable intensity using thumb. The duration for each trigger points was 1 minute. Then the muscle containing the trigger point was applied intramuscular stretching for 30 seconds by therapist

ischemic compression group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • being aged between 18-50
  • the presence of a minimum of 3 latent trigger points in Upper Trapezius, Levator Scapulae, Supraspinatus, Infraspinatus, Deltoid Anterior, Pectoralis Major, Pectoralis Minor muscles
  • no health problems
  • signed the voluntary consent form

You may not qualify if:

  • have a neck, spine or shoulder injury in the last 6 months
  • continued neck and back pain in the last 6 months
  • having a skin disease that may affect upper extremity assessment
  • malign and benign tumors
  • pain relief medication
  • having psychiatric treatment. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydın University

Istanbul, Halit Aydın Kampüsü No:38 Küçükçekmece, Turkey (Türkiye)

Location

Related Publications (3)

  • Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.

    PMID: 11871683BACKGROUND
  • Vernon H, Schneider M. Chiropractic management of myofascial trigger points and myofascial pain syndrome: a systematic review of the literature. J Manipulative Physiol Ther. 2009 Jan;32(1):14-24. doi: 10.1016/j.jmpt.2008.06.012.

    PMID: 19121461BACKGROUND
  • Unalan H, Majlesi J, Aydin FY, Palamar D. Comparison of high-power pain threshold ultrasound therapy with local injection in the treatment of active myofascial trigger points of the upper trapezius muscle. Arch Phys Med Rehabil. 2011 Apr;92(4):657-62. doi: 10.1016/j.apmr.2010.11.030.

    PMID: 21440713BACKGROUND

MeSH Terms

Conditions

Myofascial Pain SyndromesPain

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gamze G Pala, PhD

    Istanbul Aydın University

    PRINCIPAL INVESTIGATOR
  • Ebru Kaya Mutlu, Assoc.Prof.

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR
  • Hanifegül Taşkıran, Prof.

    Istanbul Aydın University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants in HPPT-US 1 group received the HPPT-US treatment (n=52). The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, and then moved the US transducer in a circle without the change of the intensity for 15 s. The procedure was repeated 3 times. Participants in HPPT-US 2 group also received the HPPT-US treatment (n=57). The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, then reduced the dose half and moved the US transducer in a circle for 15 s. The procedure was repeated 3 times.Participants in IC group received ischemic compression therapy (n=44). The duration for each trigger points was 1 minute.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 30, 2021

Study Start

October 1, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations