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

Tracking Information
First Submitted Date ICMJE	May 26, 2017
First Posted Date ICMJE	May 31, 2017
Last Update Posted Date	December 17, 2018
Actual Study Start Date ICMJE	September 25, 2017
Estimated Primary Completion Date	August 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 30, 2017)	Pain reduction [ Time Frame: Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12) ]; Pain reduction of at least 2 points on the NRS scale
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT03170557 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 30, 2017)	Persistence of pain reduction in Acupuncture arm [ Time Frame: Follow-up 2 (9 weeks after closing session 12) ]Pain reduction of at least 2 points on the NRS scale; Reduction of drugs intake [ Time Frame: 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) ]Intake reduction of antalgic, hypnotic and anxiolytic drugs (number and dosage); Reduction of Anxiety/Depression [ Time Frame: 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 anxiety/depression symptoms, assessed by Hospital Anxiety and Depression Scale; Reduction of pain interference on sleep and quality of life [ Time Frame: Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12) ]Reduction of pain interference on sleep and quality of life, assessed by Multidimensional Pain Inventory scale, Part 1; Improvement of quality of life [ Time Frame: Baseline (initial visit); closing session 12 (6 weeks); follow-up 2 (9 weeks after closing session 12) ]Increase of participation in family and social life, assessed by Multidimensional Pain Inventory scale, Part 2
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE; (submitted: May 30, 2017)	Patient satisfaction [ Time Frame: Closing session 12 (6 weeks) ]Assessment of patient satisfaction after antalgic treatment by an in-house developed ad-hoc questionnaire; Adverse events [ Time Frame: Session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12) ]Recording possible adverse events attributable to the experimental treatments
Original Other Outcome Measures ICMJE	Same as current
Descriptive Information
Brief Title ICMJE	Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation
Official Title ICMJE	A Randomized, Double Blind, Comparative Trial to Assess the Efficacy of Traditional Acupuncture vs Aspecific Needle Skin Stimulation for Persistent Pain in Subjects With Spinal Cord Injury
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.
Detailed Description	About 67% of patients with spinal cord injury (SCI) experience painful symptoms in the course of life after injury and a third evaluates the pain as "severe", with a significant impact on quality of life, due to limitations in daily activities and autonomy. Persistent pain can be of different origin and may be nociceptive, neuropathic or mixed. However, it is often poorly responsive to pharmacological therapy. For some years, attention has been paid to the use of non-pharmacological therapies and interventional techniques in treating pain, and acupuncture has been the treatment most used and appreciated for its effectiveness. Only two studies on the use of acupuncture in SCI patients were included in the only Cochrane review available, dated 2014. Such studies, focusing on the painful shoulder syndrome and, therefore, on skeletal muscle pain, show a "non-superiority" of acupuncture compared to sham acupuncture treatment or Trager approach. However, the review does not come to any clear conclusions on the effectiveness of intervention because of the small number of cases and high risk of bias. A more recent primary, randomized, controlled trial on SCI patients, although focusing on chronic pain and on a single acupuncture technique, uses a questionable study design (cross-over) to demonstrate treatment efficacy. 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. Because of the intrinsic effects of sham acupuncture and, generally, of skin stimulation, a statistically significant change in the Numerical Rating Scale (NRS) measurements is expected even in the comparison group. To minimize this bias, which cannot be avoided, and to maintain the blindness of the patient as much as possible, the comparison group is treated by the insertion of needles in skin areas outside the metamer(s) affected by pain. Primary objective: - To evaluate the efficacy of traditional acupuncture vs. aspecific needle skin stimulation for persistent pain in subjects with spinal cord injury, at the end of treatment and at the 3 week follow-up. Secondary objectives: Reduction of drug intake, at the end of treatment and at the subsequent follow-up;; Reduction of anxiety/depression, at the end of treatment and at the subsequent follow-up;; Improvement of quality of life, at the end of treatment and at the subsequent follow-up;; Persistence of the effect of acupuncture 9 weeks after treatment. Data concerning any adverse events, related to both experimental treatments of the trial, will also be collected.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Intervention Model Description: Randomized comparative trial Masking: Double (Participant, Outcomes Assessor); Masking Description: 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. Primary Purpose: Treatment
Condition ICMJE	Pain; Spinal Cord Injuries
Intervention ICMJE	Other: Traditional chinese acupuncture 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.; Other: Aspecific needle skin stimulation 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.
Study Arms	Active Comparator: Traditional chinese acupuncture Traditional chinese acupuncture. Administration of 12 sessions (2 per week for 6 weeks). Each session lasts 20-30 minutes. Intervention: Other: Traditional chinese acupuncture; Sham Comparator: Aspecific needle skin stimulation Aspecific needle skin stimulation. Administration of 12 sessions (2 per week for 6 weeks). Each session lasts 20-30 minutes. Intervention: Other: Aspecific needle skin stimulation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: May 30, 2017)	114
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	September 2019
Estimated Primary Completion Date	August 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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. Exclusion Criteria: Sporadic pain;; Mechanical ventilation;; Pregnancy;; Disorders of consciousness;; Incapacity to give informed consent in person.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Angela Morreale, MD +39 0542 632811 morreale@montecatone.com
Listed Location Countries ICMJE	Italy
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT03170557
Other Study ID Numbers ICMJE	CE-17017
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: Undecided
Responsible Party	Montecatone Rehabilitation Institute S.p.A.
Study Sponsor ICMJE	Montecatone Rehabilitation Institute S.p.A.
Collaborators ICMJE	Associazione Medici Agopuntori Bolognesi (A.M.A.B.)
Investigators ICMJE	Principal Investigator: Angela Morreale, MD Montecatone Rehabilitation Institute S.p.A.
PRS Account	Montecatone Rehabilitation Institute S.p.A.
Verification Date	December 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP