Subacromial Impingement Syndrome: Vojta Therapy vs Standard Treatment

NCT04102397 | Completed DMC

• 1 other identifier: SIS-VT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Impingement Syndrome (IS) is the most common alteration of the shoulder's articular complex of diverse etiology. Forty to 50% of those affected seek medical attention due to the pain; in half of these cases, the pain persists a year after the first medical appointment. It represents a sizeable drain on healthcare resources and a loss of productivity. Initial treatment of IS is generally conservative and includes a wide range of procedures and educational protocols. If conservative treatment fails, arthroscopy may be recommended for decompression. The standard treatment (ST) applied in the Quintanar de la Orden Physiotherapy Unit (UFQO), located within the healthcare area of Toledo, Spain, is prescribed by a rehabilitation specialist. It consists of one or more of the following procedures: transcutaneous electrical nerve stimulation (TENS), ultrasound therapy, kinesiotherapy, and cryotherapy. Reflex Locomotion - or Vojta - Therapy, is a physiotherapeutic procedure that entails all the components of human locomotion. It consists of applying stimuli to certain areas of the body with the patient in various positions in order to produce a neurophysiological facilitation of both the central nervous system and the neuromuscular system, activating global and innate locomotive patterns or complexes, namely the Creeping Reflex and the Rolling Reflex. Both complexes provoke a certain coordination of striated muscle throughout the entire body. This enables a change from pathological patterns to alternative physiological patterns that are painless, efficient, and functional, by means of generating significant global effects, including the axial extension of the spine, correct positioning of the shoulder girdle, and activation of the abdominal musculature, all of which are altered by shoulder pathologies. Therefore, because of the high prevalence of IS and the lack of scientific studies on physiotherapeutic interventions on the shoulder, the investigators decided to conduct a clinical trial on the utility of Vojta Therapy in the treatment of IS. The investigators hoped to improve on the studies published to date, which vary greatly in methodological quality and use small sample sizes and heterogeneous populations. Moreover, no published studies have examined the use of Vojta Therapy in relation to shoulder pathologies in general, or to IS in particular.

Conditions

Subacromial Impingement Syndrome; Vojta Therapy

Keywords

Subacromial Impingement Syndrome; Vojta therapy; pain

Outcome Measures

Primary Outcomes (2)

• Pain by VAS. Main result indicator. "Change" is being assessed

  Pain is measured with VAS Scale (a self-administered test). Pain graduation by VAS scale: intensity is graded from 0 ("no pain") to 10 cm ("unbearable pain"). VAS scale was given to each patient three times: after signing the informed consent form, at the end of the 15 therapy sessions, and 12 weeks after the start of the therapy.

  Through study completion, an average of 1 year and a half

• Pain by CMS. Main result indicator. "Change" is being assessed

  Pain is also measured with and Constant-Murley Scale (CMS). Maximum score for CSM measurement=35 The CMS was administered three times: the day of the initial evaluation, after 15 treatment sessions, and 12 weeks after the start of treatment - by 3 evaluating physiotherapists who had no knowledge of the assigned groups and who had not been involved with the patients' treatment.

  Through study completion, an average of 1 year and a half

Secondary Outcomes (5)

• Joint range of motion. "Change" is being assessed

  Through study completion, an average of 1 year and a half

• Strength. "Change" is being assessed

  Through study completion, an average of 1 year and a half

• Functionality by DASH. "Change" is being assessed

  Through study completion, an average of 1 year and a half

• Functionality by CMS. "Change" is being assessed

  Through study completion, an average of 1 year and a half

• Quality of life. "Change" is being assessed

  Through study completion, an average of 1 year and a half

Study Arms (2)

Standard plus Vojta therapy (SVT)

EXPERIMENTAL

The physiotherapist's hands produce the activation with no need for medication or external equipment, thus guaranteeing the patient's safety.this therapy is able to change pathological patterns to painless patterns that reduce the use of energy caused by movement difficulty. The end result is to facilitate movement without strain.

Procedure: Vojta therapy after standard therapy

Standard therapy (ST)

ACTIVE COMPARATOR

It consists of one or more of the following procedures: transcutaneous electrical nerve stimulation (TENS), ultrasound therapy, kinesiotherapy, and cryotherapy.

Procedure: Standard therapy

Interventions

Vojta therapy after standard therapy PROCEDURE

Vojta Therapy \~20 minutes/session: Application of the Reflex Creeping complex, activating several stimulus points on the facial and the nuchal sides (Figure 3a), and then the activation of the Reflex Rolling complex in both the supine position and with the patient lying on his or her side, alternating between nuchal and facial stimulation and guiding from the head.

Standard plus Vojta therapy (SVT)

Standard therapy PROCEDURE

\~50 minutes/session: * TENS Current (20 minutes, phase duration=0.10 microseconds, frequency=50 Hz). The intensity applied depended on the patient's tolerance for the treatment (Figure 2a). * Pulsating ultrasound (5 minutes around the shoulder, frequency=1MHz, intensity=1 W/cm2) (Figure 2b). * Kinesiotherapy. In stages: at first assisted (with isometric exercises), then free, and finally, with resistance, usually with elastic bands (Figure 2c). * Cryotherapy (5 minutes).

Standard therapy (ST)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients had to fulfill at least three of the following criteria:
• Pain in active Abd (70-120º), considered impingement +.
• Pain on palpation of any of the following osteotendinous insertions: infraspinatus, teres minor, supraspinatus, subscapularis, and biceps.
• Pain in any of the following isometric contractions: Abd (first 10º), internal rotation (in the anatomical position and with 90º elbow flexion), and shoulder flexion.
• Positive on the Neer test.
• Positive on Hawkins test.
• Nighttime shoulder pain.

Sponsors & Collaborators

• Castilla-La Mancha Health Service: lead
• Complejo Hospitalario La Mancha Centro: collaborator

Study Sites (1)

Unknown Facility

Quintanar de la Orden, Toledo, Spain

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Inmaculada Tello Díaz-Maroto

  Universidad Autonoma de Madrid

  STUDY CHAIR

• Jorge Lucas Torres de la Guía

  Centro de Salud Quintanar de la Orden

  STUDY CHAIR

• Carmen Jiménez-Antona

  Universidad Rey Juan Carlos de Madrid

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients that fulfilled all the inclusion criteria and gave their informed consent to participate were assigned either to the control group or to the experimental group at random and with equal probability. The randomization sequence was generated with the program EPIDAT by a researcher who was not involved in the therapeutic treatment. It consisted of random permutation blocks, each with 4 to 6 elements of length to avoid imbalances in the groups in case of attrition. The sequence was concealed in sealed, serialized, opaque envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an analytical experimental study conducted as a randomized clinical trial with two parallel intervention levels: a control group and an experimental group. All patients diagnosed with IS by a rehabilitation specialist from the La Mancha Central Hospital were referred to the UFCO, where the study was duly explained to them. The final sample consisted of those patients who fulfilled the inclusion criteria and gave their informed consent in writing.

Study Record Dates

• First Submitted: May 12, 2019
• First Posted: September 25, 2019
• Study Start: August 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: December 1, 2016
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)