Shoulder PainNCT02449668
Acupuncture Treatment of Shoulder Impingement Syndrome
A study testing Acupuncture in people with Shoulder Pain, run by Rueda, Juan Carlos, M.D., Ph.D..
Trial summary
The main objective of the current study was to assess the analgesic effect achieved to short- and medium-term by the use of acupuncture on individuals with impingement syndrome of the shoulder, in comparison to the use of acupuncture at sham points. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Nov 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- they had been diagnosed with the impingement syndrome
- compatible clinical symptoms of more than 3 months of progression
- they presented with a unilateral injury
- they had signed their informed consent.
Who cannot join
- previous surgery of the injured shoulder
- previous luxation or fracture
- neurological injuries
- illnesses with musculoskeletal disorders
About this study
Official title: Acupuncture Treatment of Shoulder Impingement Syndrome: a Randomized Controlled Trial
The main objective of the current study was to assess the analgesic effect achieved to short- and medium-term by the use of acupuncture on individuals with impingement syndrome of the shoulder, in comparison to the use of acupuncture at sham points. Furthermore, secondary objectives were also sought, such as the short- to medium-term functional recovery of the affected joint, knowing the possible influence that this has over the recovery of the laterality of the subject, as well as the development of a protocol to select points to treat pain affecting the shoulder area.
Read the detailed description
A prospective, controlled, randomized study was carried out. Two parallel, randomly separated groups were monitored. The intervention group received treatment with true acupuncture techniques (TA) on a selection of points described as effective in the literature, and the control group received treatment with acupuncture needles on sham points (SA).
The study was carried out with volunteers, who were informed about its rationale and invited to participate provided they met the following inclusion criteria: they had been diagnosed with the impingement syndrome, with compatible clinical symptoms of more than 3 months of progression; they presented with a unilateral injury; and they had signed their informed consent. Furthermore, the following exclusion criteria were also applied: previous surgery of the injured shoulder; previous luxation or fracture; neurological injuries or illnesses with musculoskeletal disorders.
All the participants who met the selection criteria were invited to an initial consultation to receive information about the study and sign consent. Each participant was randomly assigned to one of the two groups to receive a treatment with: 1) acupuncture at true local and distal points (TA) or 2) acupuncture at sham points (SA).
The random assignment of each participant to one of the two groups of the study was completed when the subjects agreed to participate and signed their consent. Each of them received a code that assigned them to one of the two groups.
The distribution of the participants in each group was also known to the main researcher, having been completed according to a random sequence of codes generated by a random generator program (Numbers®) which produced a list of values (0=acupuncture on sham points (SA); 1=true acupuncture (TA)). Each patient who joined the study received an identification number dictated by the order of their recruitment to the sample, which was matched to the list to include them in one or other of the two groups.
Each participant was informed about the sort of study they were taking part in, but they remained blind to their treatment arm at all times, during both the intervention phase and the monitoring phase.
Each participant received four acupuncture sessions, one per week. Each patient was assessed by one of the researchers in their first consultation before receiving any acupuncture session to obtain a baseline (T0), once the four treatment sessions were completed (T1) and 3 months after the end of the treatment (T2).
After examination of the existing literature, it was decided that an improvement in the perception of pain measured by the VAS (Visual Analogic Scale) of at least a decrease of 20 mm should represent achievement of a clinically significant outcome. In order to obtain a level of significance of 5% and a statistical power of 90%, it was calculated that 62 subjects had to be included in the study. After factoring in an estimated drop-out rate of 10%, a sample of 70 subjects was decided upon.
- Conditions
- Shoulder Pain
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- Acupuncture, Shoulder pain, Impingement syndrome, Rotator cuff tendinitis, Traditional Chinese medicine (TCM)
- Medical subject headings
- Shoulder Pain, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Acupuncture techniques with a plastic insertion tube was used to introduce every needle. The needles were perpendicularly inserted to a depth of 2-3 cm. The needles were applied to the area of the injured shoulder while the patient was lying in a lateral decubitus position on the stretcher. The skin was prepared with clorhexidine and the needles were sterile. They measured 40 mm long and 0.25 mm in diameter. The sessions lasted 20 minutes and the Qi sensation was sought by consistent manipulations, with rotation of the needles in both senses and scratching of the handle.
Sham AcupunctureDevice
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture on sham points (SA) | Sham comparator | The control group received treatment with acupuncture needles on sham points (SA). Receives: Device: Sham Acupuncture |
| True acupuncture (TA) | Experimental | The intervention group received treatment with true acupuncture techniques (TA) on a selection of points described as effective in the literature. Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
A 100 mm long horizontal bar Visual Analogue Scale (VAS), indicating a maximum and a minimum level of pain in every endpoint. This was used without any other data that could give information to the patient, so that it was presented as a horizontal masked bar.
Measured: Change from baseline in Visual Analogue Scale (VAS) at 3 months after the last session of acupuncture (identified like T2).
Secondary outcomes (1)
The Questionnaire of Functional Assessment of the Shoulder, University California (UCLA)
A brief questionnaire for the functional assessment of the shoulder in general terms[15] which considers 34-35 points as an excellent outcome, 33-28 points a good outcome, 27-21 a medium outcome and 20-0 as a bad outcome.
Measured: Change from baseline in Questionnaire of Functional Assessment of the Shoulder (UCLA Scale) at 3 months after the last session of acupuncture (identified like T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rueda, Juan Carlos, M.D., Ph.D.
- Responsible party
- Principal investigator, JUAN CARLOS RUEDA GARRIDO, Rueda, Juan Carlos, M.D., Ph.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449668
- Sponsor's protocol ID
- 10952-1095
- Status last verified
- May 2015
- First submitted
- 10 May 2015
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Treatment of Shoulder Impingement Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02449668
- Acronym / sponsor ID
- 10952-1095
- Conditions
- Shoulder Pain
- Keywords
- Acupuncture, Shoulder pain, Impingement syndrome, Rotator cuff tendinitis, Traditional Chinese medicine (TCM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Rueda, Juan Carlos, M.D., Ph.D.
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 May 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 main objective of the current study was to assess the analgesic effect achieved to short- and medium-term by the use of acupuncture on individuals with impingement syndrome of the shoulder, in comparison to the use of acupuncture at sham points. Furthermore, secondary objectives were also sought, such as the short- to medium-term functional recovery of the affected joint, knowing the possible influence that this has over the recovery of the laterality of the subject, as well as the development of a protocol to select points to treat pain affecting the shoulder area.
Detailed description
A prospective, controlled, randomized study was carried out. Two parallel, randomly separated groups were monitored. The intervention group received treatment with true acupuncture techniques (TA) on a selection of points described as effective in the literature, and the control group received treatment with acupuncture needles on sham points (SA).
The study was carried out with volunteers, who were informed about its rationale and invited to participate provided they met the following inclusion criteria: they had been diagnosed with the impingement syndrome, with compatible clinical symptoms of more than 3 months of progression; they presented with a unilateral injury; and they had signed their informed consent. Furthermore, the following exclusion criteria were also applied: previous surgery of the injured shoulder; previous luxation or fracture; neurological injuries or illnesses with musculoskeletal disorders.
All the participants who met the selection criteria were invited to an initial consultation to receive information about the study and sign consent. Each participant was randomly assigned to one of the two groups to receive a treatment with: 1) acupuncture at true local and distal points (TA) or 2) acupuncture at sham points (SA).
The random assignment of each participant to one of the two groups of the study was completed when the subjects agreed to participate and signed their consent. Each of them received a code that assigned them to one of the two groups.
The distribution of the participants in each group was also known to the main researcher, having been completed according to a random sequence of codes generated by a random generator program (Numbers®) which produced a list of values (0=acupuncture on sham points (SA); 1=true acupuncture (TA)). Each patient who joined the study received an identification number dictated by the order of their recruitment to the sample, which was matched to the list to include them in one or other of the two groups.
Each participant was informed about the sort of study they were taking part in, but they remained blind to their treatment arm at all times, during both the intervention phase and the monitoring phase.
Each participant received four acupuncture sessions, one per week. Each patient was assessed by one of the researchers in their first consultation before receiving any acupuncture session to obtain a baseline (T0), once the four treatment sessions were completed (T1) and 3 months after the end of the treatment (T2).
After examination of the existing literature, it was decided that an improvement in the perception of pain measured by the VAS (Visual Analogic Scale) of at least a decrease of 20 mm should represent achievement of a clinically significant outcome. In order to obtain a level of significance of 5% and a statistical power of 90%, it was calculated that 62 subjects had to be included in the study. After factoring in an estimated drop-out rate of 10%, a sample of 70 subjects was decided upon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture on sham points (SA) | Sham comparator | Device: Sham AcupunctureThe control group received treatment with acupuncture needles on sham points (SA). |
| True acupuncture (TA) | Experimental | Device: AcupunctureThe intervention group received treatment with true acupuncture techniques (TA) on a selection of points described as effective in the literature. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- they had been diagnosed with the impingement syndrome
- compatible clinical symptoms of more than 3 months of progression
- they presented with a unilateral injury
- they had signed their informed consent.
Key exclusion criteria (4 listed)
- previous surgery of the injured shoulder
- previous luxation or fracture
- neurological injuries
- illnesses with musculoskeletal disorders
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 |
|---|---|---|
| AcupunctureAcupuncture techniques with a plastic insertion tube was used to introduce every needle. The needles were perpendicularly inserted to a depth of 2-3 cm. The needles were applied to the area of the injured shoulder while the patient was lying in a lateral decubitus position on the stretcher. The skin was prepared with clorhexidine and the needles were sterile. They measured 40 mm long and 0.25 mm in diameter. The sessions lasted 20 minutes and the Qi sensation was sought by consistent manipulations, with rotation of the needles in both senses and scratching of the handle. | Device | True acupuncture (TA) |
| Sham Acupuncture | Device | Acupuncture on sham points (SA) |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Change from baseline in Visual Analogue Scale (VAS) at 3 months after the last session of acupuncture (identified like T2).
A 100 mm long horizontal bar Visual Analogue Scale (VAS), indicating a maximum and a minimum level of pain in every endpoint. This was used without any other data that could give information to the patient, so that it was presented as a horizontal masked bar.
1 secondary outcome
The Questionnaire of Functional Assessment of the Shoulder, University California (UCLA)
Time frame: Change from baseline in Questionnaire of Functional Assessment of the Shoulder (UCLA Scale) at 3 months after the last session of acupuncture (identified like T2).
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 20 May 2015.
- Trial´s abstract of Doctoral ThesisLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Shoulder Pain, run by Rueda, Juan Carlos, M.D., Ph.D..
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 4 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 20 May 2015. 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. Some participants in this study may receive a placebo. 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?
Visual Analogue Scale (VAS) (time frame: Change from baseline in Visual Analogue Scale (VAS) at 3 months after the last session of acupuncture (identified like T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2015.