- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02301468
Ischemic Compression Compared With Dry Needling
Ischemic Compression Compared With Dry Needling as a Treatment of Myofascial Trigger Points in the Neck Region in Office Workers.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Neck-shoulder pain is common in office workers and is characterized by pain and fatigue in this shoulder and neck region. Usually, the muscles around the neck and shoulder are involved in work-related neck-shoulder pain ( M. Trapezius, M. Levator Scapulae, M. Splenius Cervicis, M. Infraspinatus). Typically, sensitive spots are often present in the muscles, which are defined as trigger points.
In the treatment of trigger points both dry needling (DN) technique and ischemic compression (IC) technique are often used, supported by increasing scientific evidence.
In the dry needling (DN) technique a thin (acupuncture) needle punctures directly a trigger point with the aim to generate a "local twitch response". These are involuntary contractions of the muscle fibers that cause muscle relaxation and will recover the metabolism of the muscle. In the ischemic compression (IC) technique, pressure is applied slowly and progressively over the trigger point (upon the skin).
A randomized controlled trial will be conducted to examine the effectiveness of DN versus IC on trigger points in the neck and shoulder region for reducing pain and improving functionality (primary outcome measures) and to investigate the effectiveness of DN versus IC for muscle strength, mobility and muscle tone (secondary outcome measures).
To comply with these scientific objectives, 60 people will be recruited. The participants will be recruited within several business companies. The participants are people who perform at least 4 hours a day office work for at least one full year. All participants will get information and an informed consent with information about the study.
The subjects will be randomly assigned into two groups: one group treatment with DN, another group treatment with IC.
All participants are subjected to the baseline assessment. The baseline assessment includes the assessment of pain, functionality, muscle strength, mobility and muscle tone. Twelve triggerpoints (at a fixed location) will be localized and pain assessment of those trigger points will be performed. The four most painful trigger points (points at which they can tolerate the least pressure) will be determined. The treatment of both DN and IC will be performed on those 4 most painful trigger points and will last for four weeks in total (with a frequency of one treatment/week).
Two follow-up assessments will take place. A first follow-up assessment is provided one week post-intervention (short-term effects), in which all the tests are performed again. A second follow-up assessment is done at 3 months post-intervention (long-term effects).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged between 18 and 65 years.
- Office workers working full time and performing at least 4 hours of computer work daily participated in this study
- >15 on the Neck Disability Index (=NDI)
- Neck-shoulder pain related to trigger points
Exclusion Criteria:
- Following treatments for their complaints
- Systemic diseases
- Neurological symptoms
- Traumatic origin of the complaints
- Pregnancy
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: Dry needling
Dry needling (experimental- physiotherapy intervention) - will be performed during 4 weeks (1 treatment/week) on the 4 most painful trigger points (determined/selected at the first session - see above).
The same 4 trigger points will be treated during the 4 weeks.
DN will be performed by locating the taut band and the trigger point.
Once the trigger point is located, the overlying skin will be cleaned with alcohol.
A certified and experienced therapist will penetrate the needle through the skin 10-15mm.
into the TrP until the local twitch response will be obtained
|
(experimental- physiotherapy intervention) - will be performed during 4 weeks (1 treatment/week) on the 4 most painful trigger points (determined/selected at the first session - see above).
The same 4 trigger points will be treated during the 4 weeks.
DN will be performed by locating the taut band and the trigger point.
Once the trigger point is located, the overlying skin will be cleaned with alcohol.
A certified and experienced therapist will penetrate the needle through the skin 10-15mm.
into the TrP until the local twitch response will be obtained.
|
Experimental: Ischemic compression
Ischemic compression (experimental - physiotherapy intervention) will be performed during 4 weeks (1 treatment/week) on the 4 most painful trigger points (determined/selected at the first session - see above).
IC will be performed by applying a pressure with a wooden stick on the 4 individually determined most painful trigger points.
The duration of the pressure will be about 60s, (increase of pressure 10N/s) until the highest tolerable pressure will be reached and this pressure will be held even when the pain is decreasing during the intervention.
The subject will always be treated by the same clinician.
|
(experimental - physiotherapy intervention) will be performed during 4 weeks (1 treatment/week) on the 4 most painful trigger points (determined/selected at the first session - see above).
IC will be performed by applying a pressure with a wooden stick on the 4 individually determined most painful trigger points.
The duration of the pressure will be about 60s, (increase of pressure 10N/s) until the highest tolerable pressure will be reached and this pressure will be held even when the pain is decreasing during the intervention.
The subject will always be treated by the same clinician.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in functionality assessment NDI (Neck Disability Index) & SPADI (Shoulder Pain and Disability Index)
Time Frame: at baseline, one week after the end of the treatment sessions, at 3 months
|
Questionnaires : NDI (Neck Disability Index) & SPADI (Shoulder Pain and Disability Index)
|
at baseline, one week after the end of the treatment sessions, at 3 months
|
Pain assessment 0-10
Time Frame: at baseline
|
for 12 locations of trigger points (bilaterally for Upper Trapezius , Middle Trapezius; Splenius Cervicis , Levator Scapulae , Infraspinatus, Supraspinatus ) 12 locations of trigger points will be subject to pressure of 50N.
For each point, the subject will have to rate the pain on a 0-10 Numeric Rating Scale (NRS) (ranging from 0 (no pain) to 10 (worst possible pain).
Based on this rating, the 4 most painful points were selected for further evaluation.
|
at baseline
|
Change in Pain assessment
Time Frame: at baseline, one week after the end of the treatment sessions, at 3 months
|
Numeric rating scale Pressure Pain Treshold from the 4 most painful trigger points ( 4 (out of 12) trigger points with the highest NRS: see 2a.) Device: Digital Pressure Algometer (compuFET; Hoggan Health Industries, Inc, West Jordan, UT) For each of the 4 most painful trigger points, the threshold will be determined as the mean of 2 consecutive (30 s in between) measurements.
The PPT is the force (N) needed to give the amount of pressure that causes a changeover from sensitivity to pain in the subject.
|
at baseline, one week after the end of the treatment sessions, at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical examination of the neck and the shoulder: (no pain, little pain, much pain, Movement - no limitation, little limitation, very limited)
Time Frame: at baseline
|
Assessing pain (no pain: -, little pain: +, much pain: ++) and movement ( no limitation: - , little limitation: +, very limitated: ++ ) Neck movements: flexion - extension - sidebending ( with and without shoulder elevation), rotation and combined movements Shoulder: flexion, abduction, internal rotation, external rotation
|
at baseline
|
Change in Muscle Strength Hand Held Dynamometer (CompuFet)
Time Frame: at baseline, one week after the end of the treatment sessions, at 3 months
|
Device: Hand Held Dynamometer (CompuFet) Strength will be measured on both sides: external rotation strength test, shoulder elevation (90° of elevation in scapular plane) strength test, head extension strength test.
Each test is repeated 3 times, and the mean is calculated.
|
at baseline, one week after the end of the treatment sessions, at 3 months
|
Change in Mobility
Time Frame: at baseline, one week after the end of the treatment sessions, at 3 months
|
Device: digital inclinometer ( ACUMAR Digital Inclinometer, ACU, 360°; Lafayette Instrument Company, Lafayette, IN). The value for 2 trials will be recorded for each direction of movement.
|
at baseline, one week after the end of the treatment sessions, at 3 months
|
Change in Muscle Tone of the Trapezius muscle (bilaterally) Device: MyotonPro ®
Time Frame: at baseline, one week after the end of the treatment sessions, at 3 months
|
Device: MyotonPro ® Placed halfway the C7 and the posterolateral part of the acromion
|
at baseline, one week after the end of the treatment sessions, at 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barbara Cagnie, PhD, University Ghent
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/903
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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