Condition category
Musculoskeletal Diseases
Date applied
15/02/2005
Date assigned
04/04/2005
Last edited
15/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jorge Vas

ORCID ID

Contact details

Unidad de Tratamiento del Dolor
Centro de Salud
Dos Hermanas
41700
Spain
+34 95 47 20 370
jvas@acmas.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

82045

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Shoulder pain

Intervention

1. Acupuncture and rehabilitation
2. Transcutaneous electrical nerve stimulation (TENS) (placebo) and rehabilitation

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/02/2005

Overall trial end date

28/02/2007

Reason abandoned

Eligibility

Participant 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 Constant’s 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

465

Participant 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

Recruitment start date

01/02/2005

Recruitment end date

28/02/2007

Locations

Countries of recruitment

Spain

Trial participating centre

Unidad de Tratamiento del Dolor
Dos Hermanas
41700
Spain

Sponsor information

Organisation

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

Sponsor details

Max Plank s/n
Isla de la Cartuja
Sevilla
41092
Spain
+34 95 50 40 450
fundacion.progreso.salud.sspa@juntadeandalucia.es

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

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)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in
1. http://www.ncbi.nlm.nih.gov/pubmed/16225693
2. http://www.ncbi.nlm.nih.gov/pubmed/18403402

Publication citations

  1. Vas J, Perea-Milla E, Mendez C, Galante AH, Madrazo F, Medina I, Ortega C, Olmo V, Fernandez FP, Hernandez L, Seminario JM, Brioso M, Luna F, Gordo I, Godoy AM, Jimenez C, Ruiz MA, Montes J, Hidalgo A, Gonzalez-Quevedo R, Bosch P, Vazquez A, Lozano JV, Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220]., BMC Complement Altern Med, 2005, 5, 19, doi: 10.1186/1472-6882-5-19.

  2. Vas J, Ortega C, Olmo V, Perez-Fernandez F, Hernandez L, Medina I, Seminario JM, Herrera A, Luna F, Perea-Milla E, Mendez C, Madrazo F, Jimenez C, Ruiz MA, Aguilar I, Single-point acupuncture and physiotherapy for the treatment of painful shoulder: a multicentre randomized controlled trial., Rheumatology (Oxford), 2008, 47, 6, 887-893, doi: 10.1093/rheumatology/ken040.

Additional files

Editorial Notes