Spinal Cord Injuries Clinical Trial
Official title:
Long-term Effect of Hypnosis in Spinal Cord Injury Patients
NCT number | NCT03063333 |
Other study ID # | 240929 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 17, 2017 |
Est. completion date | November 1, 2019 |
Verified date | December 2019 |
Source | Central Jutland Regional Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Coping-oriented hypnotic suggestions aimed at reducing pain catastrophizing was shown to
reduce pain in people with chronic tension-type headache and experimental pain in healthy
volunteers during hypnosis (Kjøgx et al., 2016). However, the duration of the effect on pain
post-hypnosis is unknown.
The aim is to investigate the durational effect of a single session of coping-oriented
hypnotic suggestions on chronic pain in patients with spinal cord injury. If effective for a
longer period post-hypnosis, this form of hypnosis may provide an alternative to medicine or
may be used in conjunction with lower medicine dosages.
Methods: 75 patients with spinal cord injury and pain is randomized into one of three
conditions; coping-oriented hypnosis plus current treatment, neutral hypnosis plus current
treatment or current treatment only. Pain intensity, coping strategies, pain catastrophizing,
anxiety and depression is assessed before intervention and over a period of 14 days
post-intervention.
Status | Terminated |
Enrollment | 7 |
Est. completion date | November 1, 2019 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Spinal cord injury (tetraplegia or paraplegia) with some preservation of hand functioning - Baseline pain level of = 3 on a Numeric Rating Scale (NRS; 0-10 where 10 is extremely severe pain) - Pain duration of at least 8 weeks. Exclusion Criteria: - Severe mental or psychiatric illness - Substance abuse (drugs, alcohol or medicine) - Lack of ability to cooperate during the experiment - Severe high cervical lesions - Severe autonomic dysautonomia |
Country | Name | City | State |
---|---|---|---|
Denmark | Spinal Cord Injury Centre of Western Denmark | Viborg |
Lead Sponsor | Collaborator |
---|---|
Lone Knudsen, MSc Psych, PhD |
Denmark,
Kjøgx H, Kasch H, Zachariae R, Svensson P, Jensen TS, Vase L. Experimental manipulations of pain catastrophizing influence pain levels in patients with chronic pain and healthy volunteers. Pain. 2016 Jun;157(6):1287-96. doi: 10.1097/j.pain.0000000000000519. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Side effects | patient report | For 14 days post-intervention | |
Primary | Pain intensity | NRS (0-10) | For 14 days post-intervention | |
Primary | Coping | Coping strategies questionnaire | For 14 days post-intervention | |
Secondary | Pain catastrophizing | Pain catastrophizing scale | For 14 days post-intervention | |
Secondary | Pain impact on mood, sleep and daily activities | NRS (0-10) | For 14 days post-intervention | |
Secondary | Anxiety | Hospital Anxiety and Depression Scale | For 14 days post-intervention | |
Secondary | Depression | Hospital Anxiety and Depression Scale | For 14 days post-intervention | |
Secondary | Global impression of change | Global impression of change scale | For 14 days post-intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06321172 -
Muscle and Bone Changes After 6 Months of FES Cycling
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05484557 -
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
|
N/A | |
Suspended |
NCT05542238 -
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
|
N/A | |
Recruiting |
NCT05503316 -
The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
|
N/A | |
Not yet recruiting |
NCT05506657 -
Early Intervention to Promote Return to Work for People With Spinal Cord Injury
|
N/A | |
Recruiting |
NCT03680872 -
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
|
N/A | |
Recruiting |
NCT04105114 -
Transformation of Paralysis to Stepping
|
Early Phase 1 | |
Completed |
NCT04221373 -
Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation
|
N/A | |
Completed |
NCT00116337 -
Spinal Cord Stimulation to Restore Cough
|
N/A | |
Completed |
NCT03898700 -
Coaching for Caregivers of Children With Spinal Cord Injury
|
N/A | |
Recruiting |
NCT04883463 -
Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
|
N/A | |
Active, not recruiting |
NCT04881565 -
Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)
|
N/A | |
Completed |
NCT04864262 -
Photovoice for Spinal Cord Injury to Prevent Falls
|
N/A | |
Recruiting |
NCT04007380 -
Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
|
N/A | |
Active, not recruiting |
NCT04544761 -
Resilience in Persons Following Spinal Cord Injury
|
||
Completed |
NCT03220451 -
Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients
|
N/A | |
Terminated |
NCT03170557 -
Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation
|
N/A | |
Recruiting |
NCT04811235 -
Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial
|
N/A | |
Recruiting |
NCT04736849 -
Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury
|
N/A |