search
Back to results

Ischemic Compression Compared With Dry Needling

Primary Purpose

Neck Pain, Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dry Needling
Ischemic Compression
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Dry needling

    Ischemic compression

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    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)
    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.
    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.

    Secondary Outcome Measures

    Clinical examination of the neck and the shoulder: (no pain, little pain, much pain, Movement - no limitation, little limitation, very limited)
    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
    Change in Muscle Strength Hand Held Dynamometer (CompuFet)
    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.
    Change in Mobility
    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. Neck: flexion, extension, sidebending bilaterally Shoulder: forward flexion, abduction, internal rotation, external rotation
    Change in Muscle Tone of the Trapezius muscle (bilaterally) Device: MyotonPro ®
    Device: MyotonPro ® Placed halfway the C7 and the posterolateral part of the acromion

    Full Information

    First Posted
    November 19, 2014
    Last Updated
    December 17, 2015
    Sponsor
    University Ghent
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02301468
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Ghent

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neck Pain, Shoulder Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dry needling
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Ischemic compression
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Dry Needling
    Intervention Description
    (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.
    Intervention Type
    Other
    Intervention Name(s)
    Ischemic Compression
    Intervention Description
    (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.
    Primary Outcome Measure Information:
    Title
    Change in functionality assessment NDI (Neck Disability Index) & SPADI (Shoulder Pain and Disability Index)
    Description
    Questionnaires : 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
    Title
    Pain assessment 0-10
    Description
    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.
    Time Frame
    at baseline
    Title
    Change in Pain assessment
    Description
    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.
    Time Frame
    at baseline, one week after the end of the treatment sessions, at 3 months
    Secondary Outcome Measure Information:
    Title
    Clinical examination of the neck and the shoulder: (no pain, little pain, much pain, Movement - no limitation, little limitation, very limited)
    Description
    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
    Time Frame
    at baseline
    Title
    Change in Muscle Strength Hand Held Dynamometer (CompuFet)
    Description
    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.
    Time Frame
    at baseline, one week after the end of the treatment sessions, at 3 months
    Title
    Change in Mobility
    Description
    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. Neck: flexion, extension, sidebending bilaterally Shoulder: forward flexion, abduction, internal rotation, external rotation
    Time Frame
    at baseline, one week after the end of the treatment sessions, at 3 months
    Title
    Change in Muscle Tone of the Trapezius muscle (bilaterally) Device: MyotonPro ®
    Description
    Device: MyotonPro ® Placed halfway the C7 and the posterolateral part of the acromion
    Time Frame
    at baseline, one week after the end of the treatment sessions, at 3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Barbara Cagnie, PhD
    Organizational Affiliation
    University Ghent
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28017188
    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.
    Results Reference
    derived

    Learn more about this trial

    Ischemic Compression Compared With Dry Needling

    We'll reach out to this number within 24 hrs