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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04823013
Other study ID # B.30.2.AYD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date April 1, 2018

Study information

Verified date March 2021
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 153
Est. completion date April 1, 2018
Est. primary completion date April 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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. -

Study Design


Intervention

Other:
high power pain threshold ultrasound which the dose was kept constant
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 reduced to one half
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.
ischemic compression
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

Locations

Country Name City State
Turkey Istanbul Aydin University Istanbul Halit Aydin Kampüsü No:38 Küçükçekmece

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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)
Primary 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.
Primary 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.
Primary 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.
Primary 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)
Primary 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.
Primary 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.
Primary 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.
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