- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04348097
Comparison of Dry Needling and Activator Trigger Point Therapy on Upper Trapezius Trigger Points.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A myofascial trigger point (TrP) has been described as a hyperirritable spot located in a taut band of muscle; or a small pea or rope-like nodular or crepitant (crackling, grating) area within the muscle, which is painful to palpation or compression and refers pain, tenderness, or an autonomic response to a remote area. Some investigators stated that when pressure is applied to a TrP, a -jump sign‖ or -jump response‖ is elicited whereby the patient reacts with facial grimacing or by jumping away from the examiner.Patients with myofascial trigger points are generally characterized by the presence of one or more of the following symptoms: local pain, referred pain according to a typical pattern, pain when exerting compression or stretch on the muscle, local twitch response (LTR) provoked by the snapping palpation of the taut band, reduced force, and decreased range of motion (ROM). A combination of these symptoms can result in less functionality and quality-of-life. As a consequence, pain, ROM, and functionality are frequently used to measure the effect of treatment in patients with myofascial pain syndrome . Myofascial trigger points can be further differentiated as active or latent . Active and latent myofascial trigger points elicit local and referred pain, however active myofascial trigger points also reproduce patient symptoms, whereas latent myofascial trigger points do not .
Dry needling is a minimally invasive procedure in which an acupuncture needle is inserted directly into an myofascial trigger points.The advantages of dry needling are being increasingly documented and include an immediate reduction in local, referred, and widespread pain , and restoration of range of motion and muscle activation patterns.Dry needling is typically used to treat muscles, ligaments, tendons, subcutaneous fascia, scar tissue, peripheral nerves, and neurovascular bundles for the management of a variety of neuromusculoskeletal pain syndromes Chiropractic activator tool is an instrument for assisting with manipulation having cushioned head devices which require the applicator to pre - load or arm the device by pulling a handle against the action of a strong spring force.
A study was conducted in 2015 which concluded that Dry needling can be recommended to relieve myofacial trigger point pain of neck and shoulders in short and medium terms.
A study conducted in 2015 and found that There is moderate evidence that ischemic compression results in pain reduction, whereas there is strong evidence that dry needling has a positive effect on pain reduction. This decrease is greater compared with active range of motion exercises as well as no or placebo intervention A study conducted in 2014 and reported that dry needling is beneficial for decreasing pain immediately after treatment and at a 4-wk follow-up in patients with neck pain.
A research in 2019 showed that both extracorporeal shock wave therapy and dry needling can be employed to treat myofacial trigger point of the upper trapezius muscle in patients with non specific neck pain .
A research conducted in 2018 observed the changes in the ROM and neck disability index with Superficial dry needling and Deep dry needling techniques, but these changes were more significant in patients treated with Deep dry needling, especially in the follow-up periods A research in 2008 suggested that both ischaemic compression and activator trigger point therapy have an equal immediate clinically important effect on upper trapezius trigger point pain A study in 2008 suggested that activator trigger point therapy appeared to be more effective than myofascial band therapy or sham ultrasound in treating patients with non-specific neck pain and upper trapezius trigger points
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Islamabad, Punjab, Pakistan, 46000
- Institute of Medical Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age limit 20-45
- male and female .
- Presence of unilateral or bilateral upper trapezius Trigger Points.
- Patients identified with presence of trigger points.
Exclusion Criteria:
- Specific neck pain,
- Evidence of spinal cord compression
- Recent neck surgery or trauma.
- Long-term use of corticosteroids. Anticoagulant use, e.g. Warfarin. Presence of a blood coagulation disorder. Contraindication for needling such as local infection, pregnancy with threatened abortion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: activator trigger point therapy
The Activator adjusting instrument used had force settings ranging from 1 to 6 . For this study a force setting of 3 was used. |
activator instrument was placed perpendicular over the identified trigger point and 10 thrusts were delivered, with a rate of one thrust per second
By wrist flexion and extension movements, the trigger point was needled in different directions and tried to elicit at least one local twitch response during the procedure and patient's familiar referral pain was tried to obtain .
Each dry needling procedure lasted 1-2 minutes
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Active Comparator: Trigger point dry needling
First, a tight band was held between the index finger and the thumb of the non-dominant hand and the needle (0.25-40 mm - Shen Long) was perpendicularly inserted into the muscle with the dominant hand.
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activator instrument was placed perpendicular over the identified trigger point and 10 thrusts were delivered, with a rate of one thrust per second
By wrist flexion and extension movements, the trigger point was needled in different directions and tried to elicit at least one local twitch response during the procedure and patient's familiar referral pain was tried to obtain .
Each dry needling procedure lasted 1-2 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric pain rating scale (NPRS)
Time Frame: for three weeks
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The NPRS was used to measure the pain intensity of myofasial trigger points of the upper trapezius muscle .
NPRS is a valid and reliable tool to assess pain.
It consists of 10cm long line scale on which patient reports his/her pain from 0 (no pain) to (10 (worst possible pain)
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for three weeks
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Inclinometer
Time Frame: for three weeks
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PAOMPT Bubble inclinometer was used in our study.
Patient was educated abot the procedure.
Inclinometer was placed on patients head.
Cervical lateral flexion was recorded by stabilizing the shoulder of the patient and asking him/her to bring his/her ear towards the shoulder.
Reading was recorded by the tilt of fluid inside the inclinometer.
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for three weeks
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Algometer
Time Frame: for three weeks
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The pain pressre threshold was taken by applying vertical pressure over selected trigger point by a sixty pound baseline algometer.
Pressure was increased at the rate of 1kg/cm until the patient reported the pain by saying 'yes'.
3 readings were taken at the interval of ten seconds and mean was considered as the selected measurement
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for three weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Liu L, Huang QM, Liu QG, Ye G, Bo CZ, Chen MJ, Li P. Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):944-55. doi: 10.1016/j.apmr.2014.12.015. Epub 2015 Jan 7.
- Dunning J, Butts R, Mourad F, Young I, Flannagan S, Perreault T. Dry needling: a literature review with implications for clinical practice guidelines. Phys Ther Rev. 2014 Aug;19(4):252-265. doi: 10.1179/108331913X13844245102034.
- Yeganeh Lari A, Okhovatian F, Naimi Ss, Baghban AA. The effect of the combination of dry needling and MET on latent trigger point upper trapezius in females. Man Ther. 2016 Feb;21:204-9. doi: 10.1016/j.math.2015.08.004. Epub 2015 Aug 14.
- Ziaeifar M, Arab AM, Karimi N, Nourbakhsh MR. The effect of dry needling on pain, pressure pain threshold and disability in patients with a myofascial trigger point in the upper trapezius muscle. J Bodyw Mov Ther. 2014 Apr;18(2):298-305. doi: 10.1016/j.jbmt.2013.11.004. Epub 2013 Nov 9.
- Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.
- Cagnie B, Castelein B, Pollie F, Steelant L, Verhoeyen H, Cools A. Evidence for the Use of Ischemic Compression and Dry Needling in the Management of Trigger Points of the Upper Trapezius in Patients with Neck Pain: A Systematic Review. Am J Phys Med Rehabil. 2015 Jul;94(7):573-83. doi: 10.1097/PHM.0000000000000266.
- Ramsey FE, Tomlanovich MC, Nowak RM. Cricothyrotomy instrumentation. JACEP. 1978 Sep;7(9):345-6. doi: 10.1016/s0361-1124(78)80362-1. No abstract available.
- Jensen EV, Block GE, Ferguson DJ, DeSombre ER. Estrogen receptors in breast cancer. World J Surg. 1977 May;1(3):341-2. doi: 10.1007/BF01556853. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00464 Salman Sabir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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