Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation

NCT03170557 | Terminated

• 1 other identifier: CE-17017
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is one of the most common problems in patients with spinal cord injury (SCI) and persistent pain (that can be of different origin: nociceptive, neuropathic or mixed) is often poorly responsive to pharmacological therapy. Attention has been paid to the use of non-pharmacological therapies and interventional techniques in treating pain in other clinical conditions, and acupuncture has been the treatment most used and appreciated for its effectiveness. However, only few studies are available on the use of acupuncture in SCI patients. The present randomized, comparative trial aims to clarify the efficacy of traditional acupuncture vs. aspecific needle skin stimulation in treating persistent pain in subjects with spinal cord injury, by overcoming the biases reported in previous studies.

Conditions

Pain; Spinal Cord Injuries

Keywords

Persistent pain; Spinal cord injury; Acupuncture; Randomized Controlled Trial; RCT

Outcome Measures

Primary Outcomes (1)

• Pain reduction

  Pain reduction of at least 2 points on the NRS scale

  Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)

Secondary Outcomes (5)

• Persistence of pain reduction in Acupuncture arm

  Follow-up 2 (9 weeks after closing session 12)

• Reduction of drugs intake

  Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12); follow-up 2 (9 weeks after closing session 12)

• Reduction of Anxiety/Depression

  Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12); follow-up 2 (9 weeks after closing session 12)

• Reduction of pain interference on sleep and quality of life

  Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)

• Improvement of quality of life

  Baseline (initial visit); closing session 12 (6 weeks); follow-up 2 (9 weeks after closing session 12)

Other Outcomes (2)

• Patient satisfaction

  Closing session 12 (6 weeks)

• Adverse events

  Session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)

Study Arms (2)

Traditional chinese acupuncture

ACTIVE COMPARATOR

Traditional chinese acupuncture. Administration of 12 sessions (2 per week for 6 weeks). Each session lasts 20-30 minutes.

Other: Traditional chinese acupuncture

Aspecific needle skin stimulation

SHAM COMPARATOR

Aspecific needle skin stimulation. Administration of 12 sessions (2 per week for 6 weeks). Each session lasts 20-30 minutes.

Other: Aspecific needle skin stimulation

Interventions

Traditional chinese acupuncture OTHER

Traditional chinese acupuncture (somatopuncture points, auriculotherapy points, craniopuncture and wrist-ankle acupuncture). Simultaneously, the usual pharmacological treatment for pain is maintained, based on clinical needs.

Traditional chinese acupuncture

Aspecific needle skin stimulation OTHER

Superficial needling of needles in skin areas outside the pain affected dermatome(s). Simultaneously, the usual pharmacological treatment for pain is maintained, based on clinical needs.

Aspecific needle skin stimulation

Eligibility Criteria

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

You may qualify if:

• Persistent pain: NRS score \>2 in at least 5 assessments in 5 consecutive days, despite usual antalgic management;
• Spinal cord injury due to any etiology (both traumatic and non-traumatic);
• Spinal cord injury of any neurological level, complete or incomplete, classifiable as Asia Impairment Score (AIS) A, B, C or D;
• Stable medical conditions;
• At least 1 month away from the spinal cord injury event.

You may not qualify if:

• Sporadic pain;
• Mechanical ventilation;
• Pregnancy;
• Disorders of consciousness;
• Incapacity to give informed consent in person.

Sponsors & Collaborators

• Montecatone Rehabilitation Institute S.p.A.: lead
• Associazione Medici Agopuntori Bolognesi (A.M.A.B.): collaborator

Study Sites (1)

Montecatone Rehabilitation Institute S.p.A.

Imola, BO, 40026, Italy

Location

MeSH Terms

Conditions

Pain; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Angela Morreale, MD

  Montecatone Rehabilitation Institute S.p.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The statistician in charge for data analysis will be blind with respect to the identity of the assignment Groups (that will be coded so as not to be recognized) and will not be involved in filling data in the database to be analyzed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized comparative trial

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: September 25, 2017
• Primary Completion: January 25, 2019
• Study Completion: February 25, 2019
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

IT (1)