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Acupuncture Treatment of Shoulder Impingement Syndrome

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sham Acupuncture
Sponsored by
Rueda, Juan Carlos, M.D., Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Acupuncture, Shoulder pain, Impingement syndrome, Rotator cuff tendinitis, Traditional Chinese medicine (TCM)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • previous surgery of the injured shoulder
  • previous luxation or fracture
  • neurological injuries
  • illnesses with musculoskeletal disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Acupuncture on sham points (SA)

    True acupuncture (TA)

    Arm Description

    The control group received treatment with acupuncture needles on sham points (SA).

    The intervention group received treatment with true acupuncture techniques (TA) on a selection of points described as effective in the literature.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    May 10, 2015
    Last Updated
    May 19, 2015
    Sponsor
    Rueda, Juan Carlos, M.D., Ph.D.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02449668
    Brief Title
    Acupuncture Treatment of Shoulder Impingement Syndrome
    Official Title
    Acupuncture Treatment of Shoulder Impingement Syndrome: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rueda, Juan Carlos, M.D., Ph.D.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Pain
    Keywords
    Acupuncture, Shoulder pain, Impingement syndrome, Rotator cuff tendinitis, Traditional Chinese medicine (TCM)

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture on sham points (SA)
    Arm Type
    Sham Comparator
    Arm Description
    The control group received treatment with acupuncture needles on sham points (SA).
    Arm Title
    True acupuncture (TA)
    Arm Type
    Experimental
    Arm Description
    The intervention group received treatment with true acupuncture techniques (TA) on a selection of points described as effective in the literature.
    Intervention Type
    Device
    Intervention Name(s)
    Acupuncture
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Sham Acupuncture
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale (VAS)
    Description
    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.
    Time Frame
    Change from baseline in Visual Analogue Scale (VAS) at 3 months after the last session of acupuncture (identified like T2).
    Secondary Outcome Measure Information:
    Title
    The Questionnaire of Functional Assessment of the Shoulder, University California (UCLA)
    Description
    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.
    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).

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: previous surgery of the injured shoulder previous luxation or fracture neurological injuries illnesses with musculoskeletal disorders

    12. IPD Sharing Statement

    Links:
    URL
    http://hdl.handle.net/10952/1095
    Description
    Trial´s abstract of Doctoral Thesis

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