Effects of craniosacral therapy as adjunct to standard treatment for pelvic girdle pain in pregnant women: a multicenter, single blind, randomized controlled trial. Elden H, Ostgaard H, Glantz A, et al. Acta Obstet Gynecol Scand 2013;92:775-782.

Outline for March 2015 Pelvic PT Journal Club
Presented by: Sallie Rediske, PT, WCS

·                     Background:

A.      Compare craniosacral therapy (CST) plus standard treatment to standard treatment alone for pelvic girdle pain (PGP) during pregnancy.

·                     Subjects:    

A.      N=123.

B.      Characteristics: Healthy pregnant women, singleton fetuses 12-29 weeks gestational age; women experiencing moderate evening pain >40mm VAS during baseline week;

understood Swedish; diagnosed with PGP per European Guidelines; excluded those with history of other orthopedic conditions or surgery of spine/pelvis and systemic disease.

·                     Study Design/Methods:

A.      Multicenter, single blind, RCT.

B.      27 facilities over 17 months.

C.      Pre-trial data: demographics, BMI, parity, history of back pain, medication, life-style; one-week baseline pain/function diary; met European PGP guidelines.

D.      Pre- and post-trial SRM: Oswestry, Disability Rating Index; European QoL; pain diagram; use of sick leave, VAS.

E.       Specialist PTs completed exam: Faber, modified Trendelenburg, Symphysis pressure test, P4, ASLR.

F.       Standard treatment: education about anatomy, load, rest; provided with stabilization belt; HEP.

G.     Experimental group: standard treatment plus CST 45 min. /week x 2 weeks; every second week x 6 weeks.

·                     Blinding:

A.      YES: Examiner, statistician, and data input personnel to assigned groups.

B.      NO: participants.

·                     Results:

A.      Follow-up: cases: 56; controls: 51.

B.      Lower morning pain and less functional decline in experimental group.

C.      No effect on leave time, nor evening pain.

D.      Treatment effects did not reach minimum clinical importance on primary outcome measures (sick leave and evening pain).

·                     Limitations:

A.      Sick leave is not the same as assessing pain.

B.      Minimally clinically important differences for PGP on VAS not established; used values for LBP.

C.      Data may not have captured progressive nature of PGP in pregnancy.

D.      Inability to blind participants to intervention.

·                     Strengths:

A.      Use of valid/reliable SRM for PGP during pregnancy.

B.      All participants remained pregnant versus data capturing post-partum changes.

C.      Low drop-out rate.

D.      Verifiable diagnoses of PGP.

E.       Experienced therapists to ensure intervention comparable to CST provided clinically.

F.       Intention-to-treat analysis.

G.     Blinding of examiner.

H.      Neutral presentation of goals of trial to minimize bias.

·                     Discussion:

A.  Decreased function decline and less a.m. pain may be important outcomes for pregnant women regardless of lack of statistical significance between groups of the primary outcome measures of sick leave, evening VAS pain-level. 

·                     Conclusion:

A.      Treatment effects for use of CST in conjunction with standard intervention were small and clinically questionable given the specific outcome measures used.