Ischemic Compression Compared With Dry Needling
1 other identifier
interventional
42
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2014
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 19, 2014
CompletedFirst Posted
Study publicly available on registry
November 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedDecember 18, 2023
December 1, 2023
6 months
November 19, 2014
December 12, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Change in functionality assessment NDI (Neck Disability Index) & SPADI (Shoulder Pain and Disability Index)
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
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
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 Outcomes (4)
Clinical examination of the neck and the shoulder: (no pain, little pain, much pain, Movement - no limitation, little limitation, very limited)
at baseline
Change in Muscle Strength Hand Held Dynamometer (CompuFet)
at baseline, one week after the end of the treatment sessions, at 3 months
Change in Mobility
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 ®
at baseline, one week after the end of the treatment sessions, at 3 months
Study Arms (2)
Dry needling
EXPERIMENTALDry 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
Ischemic compression
EXPERIMENTALIschemic 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.
Interventions
(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). 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Following treatments for their complaints
- Systemic diseases
- Neurological symptoms
- Traumatic origin of the complaints
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
Related Publications (1)
De Meulemeester KE, Castelein B, Coppieters I, Barbe T, Cools A, Cagnie B. Comparing Trigger Point Dry Needling and Manual Pressure Technique for the Management of Myofascial Neck/Shoulder Pain: A Randomized Clinical Trial. J Manipulative Physiol Ther. 2017 Jan;40(1):11-20. doi: 10.1016/j.jmpt.2016.10.008.
PMID: 28017188DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Cagnie, PhD
University Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2014
First Posted
November 26, 2014
Study Start
November 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
December 18, 2023
Record last verified: 2023-12