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 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.
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
-
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.
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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.