Clinical trial NCT02301468: Ischemic Compression Compared With Dry Needling
Official title: Ischemic Compression Compared With Dry Needling as a Treatment of Myofascial Trigger Points in the Neck Region in Office Workers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Shoulder Pain
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2014-11-26
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in functionality assessment NDI (Neck Disability Index) & SPADI (Shoulder Pain and Disability Index)
timeFrame: at baseline, one week after the end of the treatment sessions, at 3 months
measure: Pain assessment 0-10
timeFrame: at baseline
measure: Change in Pain assessment
timeFrame: at baseline, one week after the end of the treatment sessions, at 3 months
Secondary outcomes:
measure: Clinical examination of the neck and the shoulder: (no pain, little pain, much pain, Movement - no limitation, little limitation, very limited)
timeFrame: at baseline
measure: Change in Muscle Strength Hand Held Dynamometer (CompuFet)
timeFrame: at baseline, one week after the end of the treatment sessions, at 3 months
measure: Change in Mobility
timeFrame: at baseline, one week after the end of the treatment sessions, at 3 months
measure: Change in Muscle Tone of the Trapezius muscle (bilaterally) Device: MyotonPro ®
timeFrame: at baseline, one week after the end of the treatment sessions, at 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University Ghent
name: Barbara Cagnie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.