Musculoskeletal DisordersNCT02617329
Extracorporeal Therapy on Shoulder and Neck Pain
A study testing Extracorporeal shock wave therapy (ESWT) and cervical flexion in people with Musculoskeletal Disorders, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this research was to investigate the clinical effects on the ESWT treatment of shoulder and neck pain. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Musculoskeletal Disorders
- What is being tested?
- Extracorporeal shock wave therapy (ESWT) and cervical flexion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2014to Jun 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non-specific shoulder and neck pain
- Ages between 20yr to 45yr
- Shoulder and neck syndrome of upper trapezius and levator scapulae more than 3 months
- No using medicine such as anodyne and muscle relaxants.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Extracorporeal Shock Wave Therapy on Shoulder and Neck Pain
The purpose of this research was to investigate the clinical effects on the ESWT treatment of shoulder and neck pain.
Read the detailed description
Extracorporeal shock wave therapy (ESWT) has been used to treat various musculoskeletal disorders. The beneficial effects of the ESWT included pain alleviation and improvement in local blood circulation. However, few study exploring the effects of the ESWT for subjects with shoulder and neck pain.
- Conditions
- Musculoskeletal Disorders
- Being tested
- Extracorporeal shock wave therapy (ESWT), cervical flexion
- Keywords
- Extracorporeal shock wave therapy (ESWT), Neck Pain
- Medical subject headings
- Musculoskeletal Diseases, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapy (ESWT)Other
The Extracorporeal shock wave therapy (ESWT) was applied on upper trapezius and levator scapulae following parameters 1.5 bar, per intervention 2000 impulse, once a week for three weeks for the experimental group
cervical flexionOther
Education have 8 movement home program for flexion, extension, side bending, rotation in neutral position, and rotation in a position of full cervical flexion.
| Study group | Role | What they receive |
|---|---|---|
| cervical flexion | Other | Education have 8 movement home program for flexion, extension, side bending, rotation in neutral position, and rotation in a position of full cervical flexion. Receives: Other: cervical flexion |
| Extracorporeal shock wave therapy (ESWT) | Other | The Extracorporeal shock wave therapy (ESWT) was applied on upper trapezius and levator scapulae following parameters 1.5 bar, per intervention 2000 impulse, once a week for three weeks for the experimental group. Receives: Other: Extracorporeal shock wave therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of visual analogue scale (VAS)
Measured: Baseline, week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 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 Musculoskeletal DisordersStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan Y Guo, Ph.D, Study chair, Department of Sports Medicine, College of Medicine, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617329
- Sponsor's protocol ID
- KMUH-IRB-20140137
- Status last verified
- Aug 2015
- First submitted
- 17 Nov 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cote P, Cassidy JD, Carroll L. The Saskatchewan Health and Back Pain Survey. The prevalence of neck pain and related disability in Saskatchewan adults. Spine (Phila Pa 1976) 23 (15): 1689-1698, 1998 Cagnie B, Danneels L, Van Tiggelen D, De Loose V, Cambier D Individual and work related risk factors for neck pain among office workers: a cross sectional study. Eur Spine J 16(5): 679-686, 2007 Lee HY, Yeh WY, Chen CW, Wang JD. psychosocial risk factors of upper extremity musculoskeletal pain in industries of Taiwan: a nationwide study. J Occup Health, 47(4): 311-318, 2005. Sjölander P, Michaelson P, Jaric S Djupsjöbacka M. Sensorimotor disturbances in chronic neck pain--range of motion, peak velocity, smoothness of movement, and repositioning acuity. Man Ther 13(2): 122-131, 2008.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Extracorporeal Shock Wave Therapy on Shoulder and Neck Pain
- ClinicalTrials.gov ID
- NCT02617329
- Acronym / sponsor ID
- KMUH-IRB-20140137
- Conditions
- Musculoskeletal Disorders
- Keywords
- Extracorporeal shock wave therapy (ESWT), Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Nov 2015 (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.
The purpose of this research was to investigate the clinical effects on the ESWT treatment of shoulder and neck pain.
Detailed description
Extracorporeal shock wave therapy (ESWT) has been used to treat various musculoskeletal disorders. The beneficial effects of the ESWT included pain alleviation and improvement in local blood circulation. However, few study exploring the effects of the ESWT for subjects with shoulder and neck pain.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cervical flexion | Other | Other: cervical flexionEducation have 8 movement home program for flexion, extension, side bending, rotation in neutral position, and rotation in a position of full cervical flexion. |
| Extracorporeal shock wave therapy (ESWT) | Other | Other: Extracorporeal shock wave therapy (ESWT)The Extracorporeal shock wave therapy (ESWT) was applied on upper trapezius and levator scapulae following parameters 1.5 bar, per intervention 2000 impulse, once a week for three weeks for the experimental group. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-specific shoulder and neck pain
- Ages between 20yr to 45yr
- Shoulder and neck syndrome of upper trapezius and levator scapulae more than 3 months
- No using medicine such as anodyne and muscle relaxants.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Extracorporeal shock wave therapy (ESWT)The Extracorporeal shock wave therapy (ESWT) was applied on upper trapezius and levator scapulae following parameters 1.5 bar, per intervention 2000 impulse, once a week for three weeks for the experimental group | Other | Extracorporeal shock wave therapy (ESWT) |
| cervical flexionEducation have 8 movement home program for flexion, extension, side bending, rotation in neutral position, and rotation in a position of full cervical flexion. | Other | cervical flexion |
Primary outcome
The change of visual analogue scale (VAS)
Time frame: Baseline, week 3
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 30 Nov 2015.
- BackgroundCote P, Cassidy JD, Carroll L. The Saskatchewan Health and Back Pain Survey. The prevalence of neck pain and related disability in Saskatchewan adults. Spine (Phila Pa 1976) 23 (15): 1689-1698, 1998 Cagnie B, Danneels L, Van Tiggelen D, De Loose V, Cambier D Individual and work related risk factors for neck pain among office workers: a cross sectional study. Eur Spine J 16(5): 679-686, 2007 Lee HY, Yeh WY, Chen CW, Wang JD. psychosocial risk factors of upper extremity musculoskeletal pain in industries of Taiwan: a nationwide study. J Occup Health, 47(4): 311-318, 2005. Sjölander P, Michaelson P, Jaric S Djupsjöbacka M. Sensorimotor disturbances in chronic neck pain--range of motion, peak velocity, smoothness of movement, and repositioning acuity. Man Ther 13(2): 122-131, 2008.
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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.
Lan Y Guo, Ph.D study chair
Department of Sports Medicine, College of Medicine, Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave therapy (ESWT) and cervical flexion in people with Musculoskeletal Disorders, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 1 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 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The change of visual analogue scale (VAS) (time frame: Baseline, week 3). 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 NCT02617329, 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 30 Nov 2015.