NCT02449668

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.9 years

First QC Date

May 10, 2015

Last Update Submit

May 19, 2015

Conditions

Shoulder Pain

Keywords

AcupunctureShoulder painImpingement syndromeRotator cuff tendinitisTraditional Chinese medicine (TCM)

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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).

Study Arms (2)

Acupuncture on sham points (SA)

SHAM COMPARATOR

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

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.

Device: Acupuncture

Interventions

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.

True acupuncture (TA)
Sham AcupunctureDEVICE
Acupuncture on sham points (SA)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Shoulder PainRotator Cuff Injuries

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

May 10, 2015

First Posted

May 20, 2015

Study Start

March 1, 2012

Primary Completion

February 1, 2014

Study Completion

November 1, 2014

Last Updated

May 20, 2015

Record last verified: 2015-05