Acupuncture and rehabilitation in the painful shoulder: a blinded randomised multicentre study

ISRCTN	ISRCTN28687220
DOI	https://doi.org/10.1186/ISRCTN28687220
Secondary identifying numbers	82045

Submission date: 15/02/2005
Registration date: 04/04/2005
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jorge Vas
Scientific

Unidad de Tratamiento del Dolor
Centro de Salud
Dos Hermanas
41700
Spain

Phone	+34 95 47 20 370
Email	jvas@acmas.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Acupuncture and rehabilitation in the painful shoulder: a blinded randomised multicentre study
Study objectives	The association of acupuncture and physiotherapy techniques for patients with chronic shoulder pain due to subacromial syndromes (rotator cuff tendinitis, subacromial bursitis and/or capsulitis), reduces pain and improves functionality to a higher degree than the application of physiotherapy alone. Moreover, the application of the former technique enables a reduction in the consumption of medication prescribed as conventional therapy, and also reduces the iatrogeny provoked by such medication, without itself producing any significant iatrogeny.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Shoulder pain
Intervention	1. Acupuncture and rehabilitation 2. Transcutaneous electrical nerve stimulation (TENS) (placebo) and rehabilitation
Intervention type	Other
Primary outcome measure	Change in the Constant-Murley score.
Secondary outcome measures	1. Changes in the intensity of diurnal pain according to visual analogic scale 2. Changes in the intensity of night-time pain according to visual analogic scale 3. Dose of non-steroidal anti-inflammatory drugs (NSAIDs) taken during the study 4. Scale of credibility of the treatment
Overall study start date	01/02/2005
Completion date	28/02/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	465
Key inclusion criteria	Patients referred to the Rehabilitation Services of health centres participating in the study and belonging to the Public Health System (Andalusian Public Health System and Murcia Public Health System). Patients presenting chronic symptoms of painful shoulder with a diagnosis of supraspinal tendinitis or subacromial bursitis. The treatment proposed is physiotherapy combined with acupuncture or with transcutaneous stimulation (TENS) - placebo. Patients will be informed of the study design and of the techniques to be employed, as well as of the possible risks (infection, lipothymia, hematomas). They will be informed that they are free to conclude their participation in the study at any time, and will suffer no kind of penalty for doing so, nor will they lose any of the benefits to which they are entitled. Selection criteria: Approval by the Ethics Committee of the reference hospital. Criteria for inclusion: 1. Patients with a clinical diagnosis of subacromial syndromes (supraspinal tendinitis or subacromial bursitis) with an evolution period greater than 3 months 2. Prior radiograph (normal) 3. Informed consent 4. Unilateral complaint The sample size was determined for a significance level of 0.05 and a power of 0.80, with a final average score of 70 on Constants Functional Evaluation Scale for the Shoulder for the experimental group (standard deviation = 17) and of 65 for the control group (standard deviation = 18), using a two-tailed test. According to data obtained from earlier studies, 188 patients are required for the experimental group and 199 for the control group. Assuming a drop-out rate of 20%, the final sample size was set at 226 patients for the experimental group and 239 for the control group.
Key exclusion criteria	1. Surgery 2. Luxations or fractures in the proximity of the shoulder 3. Other significant traumas 4. Direct or indirect (in traction) observed during anamnesis and clearly related to the onset of the episode 5. Hypocoagulates 6. Generalised disorders of the muscular-skeletal system 7. Neurological disorders 8. Vscular trophic disorders in the lower limbs 9. Lymphoedema
Date of first enrolment	01/02/2005
Date of final enrolment	28/02/2007

Locations

Countries of recruitment

Spain

Study participating centre

Unidad de Tratamiento del Dolor

Dos Hermanas
41700
Spain

Sponsor information

Foundation Progress and Health (Council of Andalusian Health Services) (Spain)
Government

Max Plank s/n
Isla de la Cartuja
Sevilla
41092
Spain

Phone	+34 95 50 40 450
Email	fundacion.progreso.salud.sspa@juntadeandalucia.es

Funders

Funder type

Government

Foundation Progress and Health, Investigation in Biomedicine, Program of Rational Use of Drugs (Fundacion Progreso y Salud, Convocatoria Investigacion en Biomedicina, Programa del Uso Racional del Medicamento, Convenio Consejeria de Salud e Instituto de Salud Carlos III) (Spain) (ref: 82045)

No information available

Council of Andalusian Health Services (Consejería de Salud, Junta de Andalucia) (136/04)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		14/10/2005		Yes	No
Results article		01/06/2008		Yes	No

Editorial Notes

26/10/2022: Internal review.