NCT02301468

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Status
completed

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

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

November 19, 2014

Last Update Submit

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

EXPERIMENTAL

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

Other: Dry Needling

Ischemic compression

EXPERIMENTAL

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.

Other: Ischemic Compression

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.

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). 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.

Ischemic compression

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

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.

MeSH Terms

Conditions

Neck PainShoulder Pain

Interventions

Dry NeedlingAcupressure

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthralgiaJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesTherapy, Soft TissueMusculoskeletal ManipulationsRehabilitation

Study Officials

  • Barbara Cagnie, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

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