Psychomotor Therapy as Complimentary Treatment to Patients With Shoulder Pain.

NCT02629783 | Completed

• 1 other identifier: S-20150111
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Some patients with shoulder pain have decreased body awareness (BA). To some degree, pain among these patients can be increased due to their lack in BA. Psychomotor therapy is thought to improve BA and thereby increase the effect of traditional therapy, such as physiotherapy and exercises. The aim of this study is therefore to investigate if psychomotor therapy, as a complimenting treatment to physiotherapy, decreases shoulder patients' function deficits and pain reported on PRO's, compared to physiotherapy alone.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Patient reported function and pain on the "Disability in the Arm, Shoulder and Hand (DASH) questionnaire"

  Patient reported generic shoulder outcome questionnaire (questions upon function and pain related limitations).

  Change from baseline DASH at 12 weeks

Secondary Outcomes (5)

• Hospital Anxiety and Depression score (HAD)

  Change from baseline HAD at 12 weeks

• Hospital Anxiety and Depression score (HAD)

  Change from baseline HAD at 24 weeks

• Pain on the NRS Scale

  Change from baseline NRS at weeks 1-24

• Multidimensional Assessment of Interoceptive Awareness (MAIA)

  Change from baseline MAIA at 12 weeks

• Multidimensional Assessment of Interoceptive Awareness (MAIA)

  Change from baseline MAIA at 24 weeks

Other Outcomes (3)

• Quality of life on "EQ-5D"

  Change from baseline EQ-5D at 12 weeks

• Quality of life on "EQ-5D"

  Change from baseline EQ-5D at 24 weeks

• Patient reported function and pain on the "Disability in the Arm, Shoulder and Hand (DASH) questionnaire"

  Change from baseline DASH at 24 weeks

Study Arms (2)

Physiotherapy + Corticosteroid injection + Psychomotor therapy

EXPERIMENTAL

Usual care + intervention

Other: Psychomotor therapy; Other: Physiotherapy; Drug: corticosteroid injection

Physiotherapy + Corticosteroid injection

ACTIVE COMPARATOR

Usual care

Other: Physiotherapy; Drug: corticosteroid injection

Interventions

Psychomotor therapy OTHER

1 treatment of approximately 45 minutes the first 5 weeks after randomization. The treatment will focus on teaching the patients about body awareness and handling of there shoulder problems in daily living.

Physiotherapy + Corticosteroid injection + Psychomotor therapy

Physiotherapy OTHER

Patients are, in secondary care setting, given 3-5 basic physiotherapy exercises for there shoulder pain, targeting rotator cuff muscles and scapula thoracic muscles. Furthermore they are given advice on seeking further physiotherapy guidance in private setting.

Physiotherapy + Corticosteroid injection; Physiotherapy + Corticosteroid injection + Psychomotor therapy

corticosteroid injection DRUG

At baseline, patients with signs of inflammation in the subacromial bursa, can receive a ultrasound guided corticosteroid injection in the bursa

Physiotherapy + Corticosteroid injection; Physiotherapy + Corticosteroid injection + Psychomotor therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>three months of should pain
• Disturbed sleep due to shoulder pain
• VAS resting pain above 2 OR VAS activity pain above 5
• MAIA score \<= 3
• Read and understand Danish.

You may not qualify if:

• Frozen shoulder
• Glenohumeral (GH) arthritis
• Rotator Cuff (RC) rupture
• GH instability
• Acromioclavicular joint arthritis
• Operation in the shoulder joint within the last six months
• Cervical problems
• Psychiatric diagnosis
• Alcohol or drug abuse

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Shoulder clinic, Orthopedic department, Hospital Lillebaelt - Vejle Hospital

Vejle, Jutland, 7000, Denmark

Location

Related Publications (1)

• Ingwersen KG, Vobbe JW, Pedersen LL, Sorensen L, Wedderkopp N. Effect of Psychomotricity in Combination With 3 Months of Active Shoulder Exercises in Individuals With Chronic Shoulder Pain: Primary Results From an Investigator-Blinded, Randomized, Controlled Trial. Arch Phys Med Rehabil. 2019 Nov;100(11):2136-2143. doi: 10.1016/j.apmr.2019.05.032. Epub 2019 Jun 24.

  PMID: 31247165 DERIVED

MeSH Terms

Conditions

Shoulder Pain

Interventions

Physical Therapy Modalities; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Lilli Soerensen, MD

  Outpatient shoulder clinic, orthopaedic department at Hospital Lillebaelt - Vejle Hospital

  STUDY CHAIR

• Kim G. Ingwersen, PhD.Fellow

  Rehabilitation department at Hospital Lillebaelt - Vejle Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: December 14, 2015
• Study Start: March 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

DK (1)