An interventional study of First data analysis and Second data analysis in Articular; Rigid, sponsored by GEMA LEÓN BRAVO. Completed at 1 site in Spain. Open to participants aged 21 Years to 76 Years. Per ClinicalTrials.gov, last updated 2022-01-13.
Sponsored by GEMA LEÓN BRAVO · Not applicable, Interventional, and Treatment
The stiff shoulder presents symptoms such as pain, loss of mobility and strength, being more common the idiopathic origin associated to the female gender. The definitive diagnosis presents complications due to the number of etiologies that can cause it. Epidemiologically, it presents from 2 to 5% of medical incapacities in the working population. Objective: To investigate the efficacy of percutaneous Neuromodulation together with Orthopedic Manual Therapy (Maitland and Mulligan) in comparison with Orthopedic Manual Therapy (Maitland and Mulligan) used in stiff shoulder.Design: Experimental clinical trial in 30 patients aged 21 to 76 years from a physiotherapy center divided into two groups: Group 1 (n=15) Percutaneous Neuromodulation + Orthopaedic Manual Therapy (Maitland and Mulligan) Group 2 (n=15) Orthopaedic Manual Therapy (Maitland and Mulligan).
The stiff shoulder is a pathology characterized by a biomechanical restriction of the active and passive movement of the shoulder, showing clinical pictures of local inflammation with a notorious hyper vascularization that helps the clinical manifestations painful flexion, stiffness, limitation of external rotation, pain over the lower cervical area or near the insertion of the deltoid muscle and pain when supporting the affected limb with body weight.
Etiologically there are idiopathic and external factors that cause disorders such as osteoarthritis, chronic subacromial bursitis, or rotator cuff tendinopathy. Likewise, trauma is involved in a secondary way as well as diseases such as Parkinson's, diabetes, thyroid disorders among others. These clinical factors present two types of diagnosis: primary idiopathic stiff shoulder and extrinsic stiff shoulder secondary to trauma or surgery.
Among the physiotherapeutic treatments provided are joint mobilizations, therapeutic exercises, deep Cyriax massage, osteopathic techniques, cryotherapy (inflammatory phase), thermotherapy (chronic phase), electrotherapy for pain and ultrasound.
From the economic point of view, it presents from 2 to 5% of the medical incapacities in the working population, being this disease one of the first 20 sick leaves that reaches up to 12 months, generating high public hospital expenses and difficulties for the business area. Due to the above, many patients enter the operating room as a quick option to return to normality. However, this option does not seem to be the best for this disease, since the hypomobility of the movement increases gradually and chronically, caused by the fibrotic processes in the anterior face of the capsule, generating long-term inability for the external rotation of the joint.
The aim of this study is to investigate the efficacy of Percutaneous Neuromodulation together with Orthopaedic Manual Therapy (Maitland and Mulligan) compared to Orthopaedic Manual Therapy (Maitland and Mulligan) used in the stiff shoulder.
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This study's enrollment of 30 is below the median of 45 across 371 interventional studies indexed under Bursitis.
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Exclusion Criteria:
15 patients in the experimental group of percutaneous neuromodulation together with orthopaedic manual therapy (Maitland and Mulligan)
Diagnostic Test: First data analysis · Procedure: Second data analysis · Other: database
15 patients in the experimental group of orthopaedic manual therapy (Maitland and Mulligan).
Diagnostic Test: First data analysis · Procedure: Second data analysis · Other: database
A series of questions were asked to a number of patients with diagnoses related to primary idiopathic stiff shoulder and/or extrinsic stiff shoulder secondary to trauma or surgery. These patients are part of the physiotherapy clinic receiving the research. This questionnaire answers basic questions for the structure of the study such as age and sex, physical behaviour during the week, endurance, athletic disability, reason for attending the clinic, exploratory motor tests, etc. Subsequently, physiotherapeutic tests related to the pathology within the research were performed consisting of joint range, percentage of shoulder disability and pain scale.
Three treatment sessions of Percutaneous Neuromodulation (PNM) and Orthopaedic Manual Therapy (OMT) (Maitland and Mulligan) (group 1) and three treatment sessions of Orthopaedic Manual Therapy (OMT) (Maitland and Mulligan) (group 2) were performed at a rate of two sessions per month for three months. These therapies were compared with the clinical examination performed prior to each new session to verify changes in joint range, percentage of shoulder disability, strength and pain scale.
Age and sex were expressed as mean ± standard deviation (SD). The rest of the variables were expressed as mean, absolute and relative frequency. The chi-square test was used to analyse the differences between the examinations in terms of the time taken and the treatments used in the two groups. A confidence level of 95% was established, considering a value of p\<0.05 as statistically significant.
Pain scale (EVA)
The values of pain levels during the examination are reflected as follows: 0= No pain 1-2= Little pain 3-4= Moderate pain 5-6= Severe pain 7-8= Very severe pain 9-10= Unbearable pain
Time frame: 3 months
Rigid shoulder type
Information on the type of stiff shoulder you have.
Time frame: 3 months
Daniels Scale
Muscle function values during the scan are reflected as follows, with 0 being a negative value and 5 a positive value: 0= Muscle does not contract. 1. Muscle contracts, but there is no movement. 2. Muscle contracts and moves normally, but without resistance. 3. Muscle contracts and resists to a good degree. 4. Muscle contracts and resists to almost its full extent. 5. The muscle contracts and resists at full amplitude.
Time frame: 3 months
Joint range
The values of joint range during the examination are reflected by means of the joint range scale which emphasizes specific degrees for elevation, external rotation and internal rotation.
Time frame: 3 months
Number of participants in each physical therapy application
Three reviews were carried out corresponding to the three months of treatment. During these three months, participants received two sessions per week, for a total of 24 sessions: * Group 1 (n=15) received the percutaneous neuromodulation treatment together with orthopedic manual therapy (Maitland and Mulligan). * Group 2 (n=15) received orthopedic manual therapy treatment (Maitland and Mulligan) only.
Time frame: 3 months
Plan to share: No — The request for the data will be studied and considered upon prior and justified request.
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