Clinical trial NCT05175586: Physiotherapeutic Case Studies in Frozen Shoulder Pathology
Official title: Physiotherapeutic Case Reports in Frozen Shoulder Pathology: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Articular; Rigid
Keywords: Stiff shoulder.
Neuromodulation.
Manual therapy.
Rotator cuff.
Physiotherapy.
Lead sponsor: Clinica Gema Leon
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 30 divided into two groups: Group 1 (n=15) percutaneous neuromodulation together with orthopaedic manual therapy (Maitland and Mulligan) Group 2 (n=15) orthopaedic manual therapy (Maitland and Mulligan).
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with difficulty in activities of daily living ABVD 35.
* Patients with positive results in some of the physical examination tests.
* Patients with a previous diagnosis by ultrasound imaging.
* Patients with surgical intervention after 3 months of age.

Exclusion Criteria:

* Patients with mental disorders or deficits.
* Patients with needle phobia (belonephobia).
* Patients with recent surgery before 3 months of age.
* Patients with previous dislocation of the affected shoulder.

Primary outcomes:
measure: Pain scale (EVA)
timeFrame: 3 months
measure: Rigid shoulder type
timeFrame: 3 months
measure: Daniels Scale
timeFrame: 3 months
measure: Joint range
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants in each physical therapy application
timeFrame: 3 months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Gema León Physiotherapy and Rehabilitation Clinic
state: Andalucía
Study officials:
affiliation: Departamento de Enfermería, Farmacología y Fisioterapia, Universidad de Córdoba, Córdoba, España
name: Gema León Bravo, Physiotherap
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Córdoba
name: Jaime Rando Anaya, Physiotherap
role: STUDY_CHAIR
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