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Table 2 Outcome measures at baseline, interim assessment, three months and follow-up

From: Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trial

 

Baseline

Interim assessment -six weeks

Three months

Follow up -six months

Informed consent

X

   

Inclusion and exclusion criteria

X

   

Demographic data

X

   

Medical and surgical history

X

   

Adverse effects

 

X

X

X

Current daily treatment

X

X

X

X

Dental status

X

X

X

X

Routine dental visit

X

   

Physical examination

X

X

X

X

Blood test (CBC, hs-CRP, serum calcium, serum creatinine, ESR, vitamin D, PTH, CTX, osteocalcin)

X

X

X

X

Pain on 100 mm VAS

X

X

X

X

EIFEL score

X

X

X

X

FABQ score

X

X

X

X

Dallas score

X

X

X

X

MacTar score

X

X

X

X

MCII/PASS score

 

X

X

X

Finger-to-floor distance

X

X

X

X

Schober’s test

X

X

X

X

Number of nightly awakenings

X

X

X

X

Severity of MS (100 mm VAS)

X

X

X

X

Duration of MS (min)

X

X

X

X

  1. CBC, complete blood count; CTX, C-terminal telopeptide; EIFEL: French adaptation of the Roland-Morris Low Back Pain Questionnaire; ESR: erythrocyte sedimentation rate; FABQ: Fear Avoidance Beliefs Questionnaire; hs-CRP: high-sensitivity C-reactive protein; MacTar: McMaster Toronto Arthritis Patient Preference Disability Questionnaire; MCII/PASS: Minimum Clinically Important Improvement/Patient Acceptable Symptom State; MS: morning stiffness; PTH: parathyroid hormone: VAS: visual analogue scale.