Clinical trial NCT04823013: 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
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Point Pain, Myofascial
Keywords: high power pain threshold ultrasound
ischemic compression
pain
trigger points
pain pressure threshold
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Pain intensity
timeFrame: 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)
measure: Beck Depression Inventory
timeFrame: 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.
measure: Neck Pain and Disability Scale
timeFrame: 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.
measure: Myofascial trigger points assessment
timeFrame: 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.
measure: Myofascial trigger points assessment
timeFrame: 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.
measure: Pain intensity
timeFrame: 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)
measure: Beck Depression Inventory
timeFrame: 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.
measure: Neck Pain and Disability Scale
timeFrame: 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.
measure: Myofascial trigger points assessment
timeFrame: 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.
measure: Pain intensity
timeFrame: 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)
measure: Beck Depression Inventory
timeFrame: 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.
measure: Neck Pain and Disability Scale
timeFrame: 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.
measure: Myofascial trigger points assessment
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydın University
state: Halit Aydın Kampüsü No:38 Küçükçekmece
Study officials:
affiliation: Istanbul Aydın University
name: Gamze G Pala, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Ebru Kaya Mutlu, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Aydın University
name: Hanifegül Taşkıran, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.
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.
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.