Shoulder PainNCT03197207
Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain
A study testing "Dragon and Tiger warring" in lifting and thrusting and "Dragon and Tiger warring" in twisting-rotating in people with Shoulder Pain, run by Chang Gung Memorial Hospital.
Trial summary
The plan " Quantitative analysis of different acupuncture needle manipulation to treat chronic shoulder pain "includes an objective observation of acupuncture operation (movement in the form of acupuncture needles, intensity, etc.) and the body (acupoints) reactions. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- "Dragon and Tiger warring" in lifting and thrusting and "Dragon and Tiger warring" in twisting-rotating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2016to 30 Dec 2016
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (A) have agreed to participate in the trial and signed by the Chang Geng Memorial Hospital Human Body Test Committee approved the human test consent.
- (B) suffering from chronic shoulder pain (including frozen shoulder, or rotator cuff injury, or subclavian bursitis, Or biceps tendonitis or nonspecific shoulder pain).
- (C) at least six weeks before the screening period of shoulder pain, digital grading scale measurement of pain intensity of 5 points or more.
Who cannot join
- (A) shoulder fracture
- (B) intra-articular infection
- (C) stroke hemiplegia
- (D) spinal cord injury
- (E) postoperative shoulder surgery
- (F) pregnant woman,
- (G) took traditional Chinese medicine or Western medicine, less than one month before the screening period
About this study
The plan " Quantitative analysis of different acupuncture needle manipulation to treat chronic shoulder pain "includes an objective observation of acupuncture operation (movement in the form of acupuncture needles, intensity, etc.) and the body (acupoints) reactions. Patients during 20-55 years old suffered shoulder pain more than six weeks with numerical rating scale (NRS) pain intensity more than 5 points, and the previous month were not taking medicine or Western medicine were included. Then use of distal acupoints GB34 and GB39, giving once acupuncture manipulation therapy.
Read the detailed description
Numerical rating scale (NRS) and pain pressure algometer were used to objective and quantitative assessment of the patient's pain. And shoulder pain and disability index-SPADI was used to objectively assess the functional changes of acupuncture treatment in patients with chronic shoulder pain. Massachusetts General Hospital Acupuncture Sensation Scale - MASS was used to get objectively record of de-qi when needle manipulation for the the body (acupoints) reactions. Acusensor2 was used to get objective observation reaction during needling manipulation, the sensor provided measurement parameters such as the lift and thrust, twisting, strength and torque during needle manipulation. Investigators will study and analysis associated clinical outcome with needling process, the needle manipulation by lifting-thrusting or twisting-rotating during the process of reinforce method or reducing method to study its dynamics and kinematics.
- Conditions
- Shoulder Pain
- Being tested
- "Dragon and Tiger warring" in lifting and thrusting, "Dragon and Tiger warring" in twisting-rotating
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Dragon and Tiger warring" in lifting and thrustingProcedure or surgery
"Tight press" slow insert in each acupoint through the superficial,intermediate, deep layer, then "tight lifting" slow withdraw needle through the deep, intermediate, superficial layer . Two acupoints (GB34, GB39) are manipulation in the process three times each during one minute, then let patients lift shoulder up and down for three times, then draw out the needle 20 minutes later.
"Dragon and Tiger warring" in twisting-rotatingProcedure or surgery
When needle insert in each acupoint through the superficial,intermediate, deep layer, within each layer twisting thumb forward nine times, then twisting backward six times. Two acupoints (GB34, GB39) are manipulation in the process during one minute, then let patients lift shoulder up and down for three times, then draw out the needle 20 minutes later.
| Study group | Role | What they receive |
|---|---|---|
| lifting and thrusting | Experimental | "Dragon and Tiger warring" in lifting and thrusting Receives: Procedure: "Dragon and Tiger warring" in lifting and thrusting |
| twisting and rotating | Experimental | "Dragon and Tiger warring" in twisting-rotating Receives: Procedure: "Dragon and Tiger warring" in twisting-rotating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numerical rating scale (NRS) during needle manipulation
Pain scale, smaller score, less pain. NRS in T0(before needle manipulation), T1(after GB34 "de-qi" ), T2(after GB34 "Dragon and Tiger warring" ), T3(after GB39 "de-qi" ), T4(after GB39 "Dragon and Tiger warring" ), T5(after Retaining Needle 20 minutes), T6(Telephone access, 24 hours later)
Measured: Through study completion, an average of 5 minutes.
Secondary outcomes (3)
Change in Pain pressure algometer (PA) during needle manipulation
The higher the score, the greater the strength that can be tolerated. PA in T0(before needle manipulation), T1(after GB34 "de-qi" ), T2(after GB34 "Dragon and Tiger warring" ), T3(after GB39 "de-qi" ), T4(after GB39 "Dragon and Tiger warring" ), T5(after Retaining Needle 20 minutes)
Measured: Through study completion, an average of 5 minutes.
Change in Massachusetts General Hospital Acupuncture Sensation Scale (MASS) during needle manipulation
objectively measure sensation associated with 'de qi' sensation. MASS in T1(after GB34 "de-qi" ), T2(after GB34 "Dragon and Tiger warring" ), T3(after GB39 "de-qi" ), T4(after GB39 "Dragon and Tiger warring" )
Measured: Through study completion, an average of 5 minutes.
Change in Shoulder Pain & Disability Index (SPADI)
13 items that assess two domains, 5-item subscale that measures pain, 8-item subscale that measures disability. T0(before needle manipulation), T5(after Retaining Needle 20 minutes), T6(Telephone access, 24 hours later)
Measured: Through study completion, an average of 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start3 Jun 2016
- Primary completion25 Aug 2016
- Study completion30 Dec 2016
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 Shoulder PainStudies of the same condition, open and under way.
- More trials run by Chang Gung 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horng-Sheng Shiue, Dr., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197207
- Sponsor's protocol ID
- 105-0313C
- Status last verified
- May 2017
- First submitted
- 11 May 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Xue HS, Zhang J. [Manipulation and comprehensive application of reinforcing-reducing methods according to numbers and directions of rotation]. Zhongguo Zhen Jiu. 2013 Sep;33(9):809-13. Chinese.
PubMed 24298773
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain
- ClinicalTrials.gov ID
- NCT03197207
- Acronym / sponsor ID
- 105-0313C
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 3 Jun 2016 (actual)
- Primary completion
- 25 Aug 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 23 Jun 2017 (actual)
- 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 plan " Quantitative analysis of different acupuncture needle manipulation to treat chronic shoulder pain "includes an objective observation of acupuncture operation (movement in the form of acupuncture needles, intensity, etc.) and the body (acupoints) reactions. Patients during 20-55 years old suffered shoulder pain more than six weeks with numerical rating scale (NRS) pain intensity more than 5 points, and the previous month were not taking medicine or Western medicine were included. Then use of distal acupoints GB34 and GB39, giving once acupuncture manipulation therapy.
Detailed description
Numerical rating scale (NRS) and pain pressure algometer were used to objective and quantitative assessment of the patient's pain. And shoulder pain and disability index-SPADI was used to objectively assess the functional changes of acupuncture treatment in patients with chronic shoulder pain. Massachusetts General Hospital Acupuncture Sensation Scale - MASS was used to get objectively record of de-qi when needle manipulation for the the body (acupoints) reactions. Acusensor2 was used to get objective observation reaction during needling manipulation, the sensor provided measurement parameters such as the lift and thrust, twisting, strength and torque during needle manipulation. Investigators will study and analysis associated clinical outcome with needling process, the needle manipulation by lifting-thrusting or twisting-rotating during the process of reinforce method or reducing method to study its dynamics and kinematics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lifting and thrusting | Experimental | Procedure: "Dragon and Tiger warring" in lifting and thrusting"Dragon and Tiger warring" in lifting and thrusting |
| twisting and rotating | Experimental | Procedure: "Dragon and Tiger warring" in twisting-rotating"Dragon and Tiger warring" in twisting-rotating |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- (A) have agreed to participate in the trial and signed by the Chang Geng Memorial Hospital Human Body Test Committee approved the human test consent.
- (B) suffering from chronic shoulder pain (including frozen shoulder, or rotator cuff injury, or subclavian bursitis, Or biceps tendonitis or nonspecific shoulder pain).
- (C) at least six weeks before the screening period of shoulder pain, digital grading scale measurement of pain intensity of 5 points or more.
Key exclusion criteria (7 listed)
- (A) shoulder fracture
- (B) intra-articular infection
- (C) stroke hemiplegia
- (D) spinal cord injury
- (E) postoperative shoulder surgery
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 |
|---|---|---|
| "Dragon and Tiger warring" in lifting and thrusting"Tight press" slow insert in each acupoint through the superficial,intermediate, deep layer, then "tight lifting" slow withdraw needle through the deep, intermediate, superficial layer . Two acupoints (GB34, GB39) are manipulation in the process three times each during one minute, then let patients lift shoulder up and down for three times, then draw out the needle 20 minutes later. | Procedure or surgery | lifting and thrusting |
| "Dragon and Tiger warring" in twisting-rotatingWhen needle insert in each acupoint through the superficial,intermediate, deep layer, within each layer twisting thumb forward nine times, then twisting backward six times. Two acupoints (GB34, GB39) are manipulation in the process during one minute, then let patients lift shoulder up and down for three times, then draw out the needle 20 minutes later. | Procedure or surgery | twisting and rotating |
Primary outcome
Change in Numerical rating scale (NRS) during needle manipulation
Time frame: Through study completion, an average of 5 minutes.
Pain scale, smaller score, less pain. NRS in T0(before needle manipulation), T1(after GB34 "de-qi" ), T2(after GB34 "Dragon and Tiger warring" ), T3(after GB39 "de-qi" ), T4(after GB39 "Dragon and Tiger warring" ), T5(after Retaining Needle 20 minutes), T6(Telephone access, 24 hours later)
3 secondary outcomes
Change in Pain pressure algometer (PA) during needle manipulation
Time frame: Through study completion, an average of 5 minutes.
Change in Massachusetts General Hospital Acupuncture Sensation Scale (MASS) during needle manipulation
Time frame: Through study completion, an average of 5 minutes.
Change in Shoulder Pain & Disability Index (SPADI)
Time frame: Through study completion, an average of 10 minutes.
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 23 Jun 2017.
- Background: PubMed 24298773Xue HS, Zhang J. [Manipulation and comprehensive application of reinforcing-reducing methods according to numbers and directions of rotation]. Zhongguo Zhen Jiu. 2013 Sep;33(9):809-13. Chinese.
- Individual participant dataSharing planned: No
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Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
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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.
Horng-Sheng Shiue, Dr. principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing "Dragon and Tiger warring" in lifting and thrusting and "Dragon and Tiger warring" in twisting-rotating in people with Shoulder Pain, run by Chang Gung Memorial Hospital.
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 3 inclusion and 7 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 23 Jun 2017. 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 Numerical rating scale (NRS) during needle manipulation (time frame: Through study completion, an average of 5 minutes.). 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 NCT03197207, 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 23 Jun 2017.