Neck PainNCT02301468
Ischemic Compression Compared With Dry Needling
A study testing Dry Needling and Ischemic Compression in people with Neck Pain and Shoulder Pain, run by University Ghent.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Neck Pain, Shoulder Pain
- What is being tested?
- Dry Needling and Ischemic Compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Following treatments for their complaints
- Systemic diseases
- Neurological symptoms
- Traumatic origin of the complaints
- Pregnancy
About this study
Official title: Ischemic Compression Compared With Dry Needling as a Treatment of Myofascial Trigger Points in the Neck Region in Office Workers.
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).
Read the 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).
- Conditions
- Neck Pain, Shoulder Pain
- Being tested
- Dry Needling, Ischemic Compression
- Medical subject headings
- Neck Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
(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 CompressionOther
(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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Ischemic Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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)
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
Measured: at baseline
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.
Measured: at baseline, one week after the end of the treatment sessions, at 3 months
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
Measured: 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 ®
Device: MyotonPro ® Placed halfway the C7 and the posterolateral part of the acromion
Measured: at baseline, one week after the end of the treatment sessions, at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Cagnie, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301468
- Sponsor's protocol ID
- 2013/903
- Status last verified
- Dec 2023
- First submitted
- 19 Nov 2014
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28017188
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Compression Compared With Dry Needling as a Treatment of Myofascial Trigger Points in the Neck Region in Office Workers.
- ClinicalTrials.gov ID
- NCT02301468
- Acronym / sponsor ID
- 2013/903
- Conditions
- Neck Pain, Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry NeedlingDry 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 | Other: Ischemic CompressionIschemic 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Following treatments for their complaints
- Systemic diseases
- Neurological symptoms
- Traumatic origin of the complaints
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 - 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 |
Primary outcome
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)
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.
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.
4 secondary outcomes
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
Change in Muscle Strength Hand Held Dynamometer (CompuFet)
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 28017188De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Cagnie, PhD principal investigator
University Ghent
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Ischemic Compression in people with Neck Pain and Shoulder Pain, run by University Ghent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023; AzTrials last refreshed its copy on 26 Oct 2026.