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Comparison of High Power Pain Threshold Ultrasound and Ischemic Compression Techniques for Treatment of Trigger Points

Primary Purpose

Trigger Point Pain, Myofascial

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
high power pain threshold ultrasound which the dose was kept constant
high power pain threshold ultrasound which the dose reduced to one half
ischemic compression
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Point Pain, Myofascial focused on measuring high power pain threshold ultrasound, ischemic compression, pain, trigger points, pain pressure threshold

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Istanbul Aydın University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

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

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

ischemic compression group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Pain intensity
Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels
Beck Depression Inventory
Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.
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.
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
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
Pain intensity
Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels
Beck Depression Inventory
Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.
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.
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
Pain intensity
Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels
Beck Depression Inventory
Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.
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.
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

Secondary Outcome Measures

Full Information

First Posted
March 24, 2021
Last Updated
March 26, 2021
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04823013
Brief Title
Comparison of High Power Pain Threshold Ultrasound and Ischemic Compression Techniques for Treatment of Trigger Points
Official Title
Comparison of High Power Pain Threshold Ultrasound and Ischemic Compression Techniques for the Treatment of Latent Myofascial Trigger Points: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Myofascial trigger points 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 treatment techniques aimed to return the fiber groups affected by myofascial trigger points to their normal length and endplates to their normal function. Although both ischemic compression and two different application methods of high power pain threshold ultrasound techniques are effective methods in the treatment of trigger points , there are no studies showing which technique is more effective. It is aimed to to compare the efficacy of ischemic compression and two different application methods of high power pain threshold ultrasound techniques on myofascial trigger point treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Point Pain, Myofascial
Keywords
high power pain threshold ultrasound, ischemic compression, pain, trigger points, pain pressure threshold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high power pain threshold ultrasound which the dose was kept constant group (HPPT-US 1)
Arm Type
Experimental
Arm Description
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.
Arm Title
high power pain threshold ultrasound which the dose reduced to one half group (HPPT-US 2)
Arm Type
Experimental
Arm Description
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.
Arm Title
ischemic compression group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
high power pain threshold ultrasound which the dose was kept constant
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
high power pain threshold ultrasound which the dose reduced to one half
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
ischemic compression
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels
Time Frame
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)
Title
Beck Depression Inventory
Description
Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.
Time Frame
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.
Title
Neck Pain and Disability Scale
Description
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.
Time Frame
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.
Title
Myofascial trigger points assessment
Description
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
Time Frame
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.
Title
Myofascial trigger points assessment
Description
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
Time Frame
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.
Title
Pain intensity
Description
Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels
Time Frame
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)
Title
Beck Depression Inventory
Description
Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.
Time Frame
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.
Title
Neck Pain and Disability Scale
Description
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.
Time Frame
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.
Title
Myofascial trigger points assessment
Description
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
Time Frame
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.
Title
Pain intensity
Description
Pain intensity is of valuable diagnostic information, and we ask patients to evaluate how strong their pain feels
Time Frame
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)
Title
Beck Depression Inventory
Description
Depression is a constant feeling of sadness and loss of interest, which stops you doing your normal activities.
Time Frame
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.
Title
Neck Pain and Disability Scale
Description
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.
Time Frame
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.
Title
Myofascial trigger points assessment
Description
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
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze G Pala, PhD
Organizational Affiliation
Istanbul Aydın University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ebru Kaya Mutlu, Assoc.Prof.
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanifegül Taşkıran, Prof.
Organizational Affiliation
Istanbul Aydın University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Aydın University
City
Istanbul
State/Province
Halit Aydın Kampüsü No:38 Küçükçekmece
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11871683
Citation
Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.
Results Reference
background
PubMed Identifier
19121461
Citation
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.
Results Reference
background
PubMed Identifier
21440713
Citation
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.
Results Reference
background

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Comparison of High Power Pain Threshold Ultrasound and Ischemic Compression Techniques for Treatment of Trigger Points

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